Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2019 – 30.09.2019

Великобританія

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

Kiwi Complete Vacuum Delivery System – risk of failure to achieve or maintain vacuum during use (specific lot affected) (MDA2019/031)

Manufactured by Clinical Innovations – if the device fails to generate or maintain a vacuum during the assisted delivery of a baby, additional intervention will be needed.

Alert type: Medical device alert

Medical specialism: Obstetrics and gynaecology

Issued: 30 September 2019

All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030)

Manufactured by CME (a BD company) – function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices.

Alert type: Medical device alert

Medical specialism: Care home staff and 3 others

Issued: 18 September 2019

Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion

Manufactured by Smiths Medical: due to a manufacturing process failure, needles may be occluded, potentially causing a delay to treatment.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 13 others

Issued: 12 September 2019

Microneedling pens: Dermapen 3 and Dermapen Cryo Sterile single use needle cartridge tips for: Dermapen 3 – risk of injury or infection (MDA/2019/028)

Manufactured by Equipmed and other trading names (listed in the ‘Manufacturer contacts’ section), distributed in the UK by Naturastudios.

Alert type: Medical device alert

Medical specialism: Cosmetic surgery and 1 others

Issued: 27 August 2019

Automated external defibrillators: All Telefunken HR1 & FA1 – no valid CE certificate (MDA/2019/027)

Manufactured by Defiteq International BV or GGT Holding BV – the safety and performance of these devices cannot be verified and their safe use can no longer be assured.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 21 others

Issued: 25 July 2019

Professional use capillary blood specimen collection: BD Microtainer® tubes – risk of blood leakage and/or incorrect test results due to defective tubes

Manufactured by Becton Dickinson (BD) – tubes may contain a hole or be damaged or deformed, potentially causing blood leakage and/or an inadequate blood-to-additive ratio leading to incorrect test results.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 13 others

Issued: 24 July 2019

IntelliVue MX40 patient-worn monitors – increased power consumption and no visual or audible alarms when batteries are low (MDA/2019/025)

Manufactured by Philips – devices may lose power earlier than expected and users may not realise the loss of monitoring due to no alarm, which could contribute to a delay in emergency treatment.

30.09.2019	SEBAG SENECTOVIA Medizinaltechnik AG	Phoenix Ergocare Intensiv-Pflegebett	MD: Beds; Beds, Electric; Beds, Electric,Obese	DE-1	Vk_20190930_16
27.09.2019	Lohmann & Rauscher GmbH & Co. KG	Cardboard Kidney Shell in KitPack (set system) Lot: all sets sytems with running expiry date	MD: Bowls, Sponge Collection	DE-1	Vk_20190923_05
27.09.2019	CooperSurgical Inc.	Embryology Heated Plate within the RI WitnessTM Model: 6-70-807, 6-70-807-A, 6-70-807-B S/N: See FSN	MD: Assisted reproduction heater/incubator	DE-1 FR-1 IT-1 EN-1	Vk_20190920_16
26.09.2019 (Updated 27.09.2019)	Smith & Nephew Orthopaedics AG	RT-PLUS MODULAR FEMORAL BLOCK Model: 75005579; 75005585; 75005587 Lot: D1416197; D1416198; D1416199	MD: Knee arthroplasty wedge	DE-1 FR-1 IT-1 EN-1	Vk_20190920_03
27.09.2019	Axis-Shield Diagnostics Limited	Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE Model: FHBC100, FHRWR100/200/1000 Lot: 902924530, 902925703, 902924526, 902925702, 902924829	IVD: Homocysteine IVD, reagent	EN-1	Vk_20190917_08
26.09.2019	Siemens Healthcare Diagnostics Inc	Atellica 1500 Automated Urinalysis System Atellica UAS 800 analyzer Model: SMN 11065004 Lot: N/A S/N: N/A SW-Version: All versions up to and including V4.0.220	IVD: Urine analyser IVD, laboratory, automated IVD: Urine analyser IVD, laboratory, automated	FR-1 EN-1	Vk_20190923_12
26.09.2019	Hain Lifesciences GmbH	Substrate Buffer (SUB-D) of the GenoType Test Systems from Hain Lifescience GmbH Model: 88896, 34496, 29996A, 23396, 34196, 25296, 24196, 23296, 33796, 30196, 29596, 24596, 29796, 29896, 29996, 31796, 30496AGL, 30496A Lot: SUB-D lot numbers G0119 and G0319	IVD: Buffers	EN-1	Vk_20190923_01
25.09.2019	Bühlmann Laboratories AG	BÜHLMANN GanglioCombi MAG ELISA Model: EK-GCM Lot: 2030, 2030.1, 2131	IVD: Ganglioside total antibody IVD, kit, enzyme immunoassay (EIA)	EN-1	Vk_20190918_05
25.09.2019	Codman & Shurtleff, Inc	Codman ISOCOOL AHT Bipolar Forceps Tips Model: 8145100S Lot: J2670Y	MD: Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	FR-1 EN-1	Vk_20190918_01
10.09.2019 (Updated 23.09.2019)	Medtronic Inc.	Euphora and Solarice Rapid Exchange Balloon Dilatation Catheter Model: See FSN Lot: See FSN	MD: Coronary angioplasty balloon catheter, basic	DE-1 FR-1 EN-1	Vk_20190909_06
30.08.2019 (Updated 23.09.2019)	Beckman Coulter	Triglycerides GPO Blanked Model: 445850 Lot: all Urin Acid Model: 442785 Lot: all Total Bilirubin Model: 442745, 476861 Lot: all Direct Bilirubin Model: 439715, 476856 Lot: all Enzymatic Creatinine Model: A602298 Lot: all	IVD: Triglyceride IVD, kit, enzyme spectrophotometry IVD: Uric acid IVD, kit, enzyme spectrophotometry IVD: Total bilirubin IVD, kit, spectrophotometry IVD: Conjugated (direct) bilirubin IVD, kit, spectrophotometry IVD: Creatinine IVD, kit, enzyme spectrophotometry	DE-2 FR-1 EN-1	Vk_20190823_01
20.09.2019	MedTech - Zimmer Biomet Robotics	ROSA Brain S/N: BR16027, BR16028, BR17033, BR16029 SW-Version: 3.0.0.21	MD: Neurological stereotactic surgery system	FR-1 EN-1	Vk_20190913_11
20.09.2019	Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)	Blanketrol III Model: 86001, 86203, 86204, 86207 S/N: All Blanketrol III manufactured in the past 12 years.	MD: Circulating-fluid whole-body heating/cooling system control unit	DE-1 FR-1 IT-1	Vk_20190912_07
20.09.2019	Johnson & Johnson Vision Care	1-DAY ACUVUE MOIST for Astigmatism Lot: 395749, 395750, 395751	MD: Soft corrective contact lens, daily-disposable	DE-1 FR-1 IT-1	Vk_20190911_06
19.09.2019	ArcRoyal uc, an Owens and Minor Company	Medline Sterile Absorbent Cotton O.R Towels Model: 10-007081	MD: Surgical towel	DE-1 EN-1	Vk_20190916_28
18.09.2019	Abbott Ireland Diagnostic Division	Alinity i STAT Myoglobin Reagent Kit Model: 04V3720 Lot: 04436FN00	IVD: Myoglobin IVD, kit, chemiluminescent immunoassay	EN-1	Vk_20190910_16
18.09.2019	HemoCue AB	HemoCue 201 DM - DMS Software CD and HemoCue Glucose 201 DM RT System Model: 131050, 131071 SW-Version: 3.0	IVD: Glucose monitoring system IVD, point-of-care	EN-1	Vk_20190910_15
17.09.2019	W.O.M. World of Medicine GmbH	Aquilex Fluid Control System Model: AQL-100CBS S/N: See FSN	MD: Hysteroscopic irrigation/insufflation system	DE-1 FR-1 EN-1	Vk_20190912_14
17.09.2019	Datex Ohmeda	Aespire Model: 7100/100/Protiva/Carestation SW-Version: 1.x Aestiva Model: 7100, 7900, MRI SW-Version: 1.x, 2.x, 3.x	MD: Neonatal/adult intensive-care ventilator MD: Neonatal/adult intensive-care ventilator	DE-1 FR-1 IT-1	Vk_20190910_17
03.09.2019 (Updated 17.09.2019)	Pivotal Health Solutions	Epidural Positioning Device Model: EPD Package 2	MD: Positioning aid	FR-1 EN-1	Vk_20190828_06
16.09.2019	CeMed GmbH	OP-Sets Model: 76065	MD: Nierenschalen aus Faserformmaterial	DE-1	Vk_20190910_12
16.09.2019	Omni-Pac Ekco GmbH	MediTainer Model: all Lot: all MediBowl Model: all Lot: all MediDuo Model: all Lot: all	MD: Bowl MD: Sheet, examination table MD: Bowl	DE-1 FR-1 EN-1	Vk_20190910_11
16.09.2019	Philips Goldway (Shenzhen) Industrial Inc.	Efficia DFM 100 Model: 866199 S/N: UAL86000260	MD: Rechargeable professional automated external defibrillator	DE-1 FR-1 IT-1 EN-1	Vk_20190902_08
24.07.2019 (Updated 16.09.2019)	Radiometer Medical ApS	AQURE system Model: 933-599 SW-Version: Below Version 2.3.5 (i.e. 2.3.5. not included)	IVD: Medical equipment clinical data interfacing software	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-1 EN-2	Vk_20190719_06
26.06.2019 (Updated 16.09.2019)	Roche Diagnostics GmbH	MYO2 (Tina-quant Myoglobin Gen.2) Model: 04580010190 Lot: see FSN	IVD: Myoglobin IVD, kit, chemiluminescent immunoassay	EN-1 EN-2 EN-3	Vk_20190621_05
13.09.2019	DiaMed GmbH	DC Screening II Model: 004831, 004836, 004837 Lot: 50560 94 01, 50560 94 02, 50560 94 03	IVD: Polyspecific antihuman globulin/complement IVD, antibody, agglutination	EN-1	Vk_20190911_05
13.09.2019	Medset Medizintechnik GmbH	Patientenkabel, EKG Verstärkers BT-12 Model: AAZ135512-03	MD: Cable/lead, ECG	DE-1	Vk_20190906_04
13.09.2019 (Updated 13.09.2019)	DiaSys Diagnostic Systems GmbH	CRP FS Model: 1 7002.. Lot: 24753, 25005	IVD: C-Reactive Protein IC RT/POC => 12.70.11.01	DE-1 EN-1	Vk_20190903_05
11.09.2019	EIZO Corporation	RadiForce Model: GX560, RX360 S/N: GX560 (serial numbers: 20001* - 22874), RX360 (serial numbers: 20001 - 28451*)	MD: Image display monitor, colour	DE-1 FR-1 IT-1	Vk_20190903_04
10.09.2019	Gentherm Medical, LLC (formerly Cincinnati Sub-Zero)	Norm-O-Temp Model: 111Z; 111W	MD: Circulating-fluid whole-body heating/cooling system control unit	DE-1 FR-1 IT-1	Vk_20190909_11
10.09.2019	Siemens Healthcare Diagnostics Inc	Atellica 1500 Automated Urine Sediment Analyzer Model: SMN 11065004 SW-Version: V4.0.200 and V4.0. 220 Atellica UAS 800 Analyzer Model: SMN 11065004 SW-Version: V4.0.200 and V4.0. 220	IVD: Urine analyser IVD, laboratory, automated IVD: Urine analyser IVD, laboratory, automated	FR-1	Vk_20190904_13
02.04.2019 (Updated 10.09.2019)	Datex-Ohmeda Inc., Ohmeda Medical a division of Datex-Ohmeda	Panda iRes Warmer S/N: See FSN Giraffe Warmer S/N: See FSN	MD: Infant warmer MD: Infant warmer	DE-1 DE-2 FR-1 FR-2 IT-1 IT-2 EN-2	Vk_20190401_22
09.09.2019	Tem Innovations GmbH	EXTEM Model: 000503-05 Lot: 42255701	IVD: Other Other Haemostasis Reagents	DE-1 EN-1	Vk_20190830_16
09.09.2019	Motekforce Link B.V.	Body Weight Support (BWS) Light Model: RB011 Lot: see FSN	MD: Treadmill/elliptical gait rehabilitation system, automated-guidance	DE-1 DE-2 FR-2 EN-1 EN-2	Vk_20190829_01
03.09.2019 (Updated 09.09.2019)	Olympus Medical Systems Corp.	SINGLE USE SUCTION VALVE Model: MAJ-209, 028978 Lot: 88H, 89H, 8XH, 8YH, 8ZH, 91H	MD: Endoscopic procedure air/water valve, single-use	DE-1 FR-1 IT-1 EN-1	Vk_20190828_17
06.09.2019	munevo GmbH	munevo Drive S/N: MD18V10001-MD18V10030	MD: Wheelchair steering/control unit	DE-1 FR-1 IT-1 EN-1	Vk_20190826_16
03.09.2019 (Updated 05.09.2019)	Mölnlycke Health Care AB	Barrier Sets Model: see fsn Lot: see fsn	MD: General/plastic surgical procedure kit, non-medicated, single-use	DE-2 FR-2 IT-2 EN-1 EN-2	Vk_20190830_09
05.09.2019	Becton, Dickinson & Company	BD FACSLyric Flow Cytometer Model: 651164; 651165; 654587; 659180; 663029 Lot: refer to FSN	IVD: Flow cytometry analyser IVD, automated	DE-1 FR-1 IT-1 EN-1	Vk_20190827_11
05.09.2019	Spiggle & Theis Medizintechnik GmbH	Panetti suction separator Model: 10-808-12 Lot: 045/02-18	MD: Suction Tips, General-Purpose	DE-1 FR-1 IT-1 EN-1	Vk_20190822_14
27.08.2019 (Updated 05.09.2019)	Limacorporate S.p.a.	Revision-LR stem Model: see FSN Lot: see FSN Modulus-R stem Model: see FSN Lot: see FSN Revision stem Model: see FSN Lot: see FSN Modulus stem Model: see FSN Lot: see FSN	MD: Uncoated hip femur prosthesis, modular MD: Uncoated hip femur prosthesis, modular MD: Uncoated hip femur prosthesis, modular MD: Uncoated hip femur prosthesis, modular	DE-1 FR-1 EN-1	Vk_20190821_01