Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.07.2018 – 30.09.2018

Великобританія

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

·         Various trauma guide wires – risk of infection due to packaging failure (MDA/2018/032)

Manufactured by Zimmer Biomet with expiry dates prior to 31 May 2028 – wire may breach packaging, compromising sterility of device.

Medical device alert

General surgery and 3 others

Issued: 24 September 2018

·         SureSigns VS & VM patient monitors and Viewing stations manufactured before May 2018: risk of batteries overheating or igniting (MDA/2018/031)

Manufactured by Philips – Lithium ion batteries which have exceeded their specified replacement interval or number of charging cycles are at risk of overheating or igniting.

Medical device alert

Anaesthetics and 13 others

Issued: 19 September 2018

·         Flex connectors in Halyard Closed Suction Kits – risk of interruption of ventilation (MDA/2018/030)

Manufactured by Halyard Health – risk of some Flex Connectors in Closed Suction Kits becoming loose or disconnecting, which may interrupt patient ventilation.

Medical device alert

Anaesthetics and 2 others

Issued: 19 September 2018

·         BenchMark Automated Slide Stainer series – FLO LOK III Reagent Dispenser Issue for IHC and ISH kits including INFORM HPV III Family 16 Probe (B) (MDA/2018/029)

Roche (Ventana Medical Systems) has released an expansion of products affected by the reagent dispenser issues causing weak staining and the potential for false negative results and misdiagnosis.

Medical device alert

General surgery and 3 others

Issued: 13 September 2018

·         Orthopaedic bone plates and cortical screws: ADVANSYS MLP-DLP; ADVANSYS TTC; Large QWIX; TIBIAXYS and UNI-CP–Sterile – Risk of infection (MDA/2018/028)

Manufactured by Newdeal SAS – Risk of infection from compromised packaging.

Medical device alert

Orthopaedics

Issued: 1 August 2018

·         Breast implants, all types, makes and models – Continue to report suspected cases of Breast Implant Associated – Anaplastic Large Cell Lymphoma (MDA/2018/027)

UK update on Breast Implant Associated – Anaplastic Large Cell Lymphoma (BIA – ALCL)

Medical device alert

Cosmetic surgery and 4 others

Issued: 25 July 2018

·         First generation JOURNEY BCS Knee System– Higher than expected risk of revision (MDA/2018/026)

Manufactured by Smith & Nephew – The device has a higher than expected risk of revision due to early component loosening.

Medical device alert

Orthopaedics

Issued: 23 July 2018

·         Novaline haemodialysis bloodlines used with Baxter/Gambro haemodialysis machines – Recall of specific products due to various problems encountered during clinical use (MDA/2018/025R)

Manufactured by Vital Healthcare Sdn for distribution by Baxter Healthcare Ltd – specific product codes manufactured in 2017 have functional and assembly issues which may lead to air entering the system, blood loss, clotting and delays in treatment.

Medical device alert

Anaesthetics and 2 others

Issued: 12 July 2018

·         All Alaris™ and Asena™ GS, GH, CC, TIVA, PK, enteral syringe pumps – risk of uncontrolled bolus of medicine (MDA/2018/024R)

Manufactured by CareFusion, now Becton Dickinson (BD) Medical – identify and replace the back-plate in the plunger assembly and note updated preventative maintenance schedule for these pumps.

Medical device alert

Anaesthetics and 13 others

Issued: 12 July 2018

·         SAM XT Extremity Tourniquet – Recall due to the risk of tourniquet failing in use

Manufactured by SAM Medical Products – An error in the manual sewing operations of devices manufactured from March 2017 to April 2018 may cause the seam holding the buckle to the belt to fail.

Medical device alert

Issued: 6 July 2018

·         Combur10 Test UX and Chemstrip 10 A test strips – risk of falsely low results when measuring test strips on the Urisys 1100 urine analyser

Manufactured by Roche Diagnostics GmbH – Incorrect Limit of Detection (LoD) for protein, nitrite, ketone bodies, leukocytes, blood: intact erythrocytes, which may adversely impact patient treatment.

Medical device alert

Issued: 5 July 2018