Великобританія
· Field Safety Notice - 23 to 27 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017.
Alert type: Field safety notice Medical specialism: Anaesthetics and 16 others Issued: 30 October 2017
· Field Safety Notice - 23 to 27 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 23 to 27 October 2017. Alert type: Field safety notice Medical specialism: Anaesthetics and 16 others
Issued: 30 October 2017
· Field Safety Notice - 9 to 13 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 2017.
Alert type: Field safety notice Medical specialism: Anaesthetics and 21 others Issued: 16 October 2017
· Field Safety Notice - 9 to 13 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 9 to 13 October 2017.
Alert type: Field safety notice Medical specialism: Anaesthetics and 21 others Issued: 16 October 2017
· Field Safety Notice - 16 to 20 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 October 2017.
Alert type: Field safety notice Medical specialism: Anaesthetics and 21 others Issued: 24 October 2017
· Field Safety Notice - 16 to 20 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 16 to 20 October 2017.
Alert type: Field safety notice Medical specialism: Anaesthetics and 21 others Issued:24 October 2017
· Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API)
Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
Alert type: Drug alert Medical specialism: Anaesthetics and 6 others Issued: 17 October 2017
· Class 4 medicines defect information: some batches of Gentamicin Sulphate Active Pharmaceutical Ingredient (API)
Caution in Use: Distribute to Hospital Pharmacy, Ward and Operating Theatre Level
Alert type: Drug alert Medical specialism: Anaesthetics and 6 others Issued: 17 October 2017
· Field Safety Notice - 02 to 06 October 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
Alert type:
Field safety noticeIssued:9 October 2017
· Professional use HIV test: Alere HIV Combo – risk of false positive results
Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected.
Alert type:
Medical device alert Medical specialism: General practice and 3 others Issued: 3 October 2017
· Professional use HIV test: Alere HIV Combo – risk of false positive results
Manufactured by Alere – point-of-care tests for use ONLY in professional clinical settings: specific lots are affected.
Alert type: Medical device alert Medical specialism: General practice and 3 others Issued:
3 October 2017
· Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients
Manufactured by Maquet/Gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients
Alert type: Medical device alert Medical specialism: Anaesthetics and 4 others Issued:3 October 2017
· Intra-aortic balloon pump (IABP): Maquet/Datascope CS100, CS100i and CS300 – potential for interruption or delay to therapy of critically ill patients
Manufactured by Maquet/Gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients
Alert type:
Medical device alert Medical specialism: Anaesthetics and 4 others Issued:
3 October 2017
· Field Safety Notice - 25 to 29 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
Alert type:
Field safety notice Medical specialism: Anaesthetics and 21 othersIssued:
2 October 2017
· Field Safety Notice - 25 to 29 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 25 to 29 September 2017.
Alert type:
Field safety notice Medical specialism:Anaesthetics and 21 othersIssued:
2 October 2017
· Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban)
Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
Alert type:
Drug alert Medical specialism: Anaesthetics and 21 others Issued: 29 September 2017
· Class 2 Medicines Recall: Xarelto 20 mg film-coated tablets (Rivaroxaban)
Strathclyde Pharmaceuticals Ltd is recalling a single batch of Xarelto 20mg film-coated tablets (Rivaroxaban) because of reports of rogue blister strips of 15 mg tablets within two packs of 20 mg tablets.
Alert type: Drug alert Medical specialism: Anaesthetics and 21 others
Issued:
29 September 2017
· IntelliVue patient monitors used with 12-lead ECG – risk of ECG trace distortion Specific models and software versions affected.
Manufactured by Philips Healthcare: Error messages reporting a damaged or incorrectly functioning cable can trigger automatic corrective filtering of the ECG trace, distorting the ST segment, leading to risk of misinterpretation or misdiagnosis. (MDA/2017/031)
Alert type:
Medical device alert Medical specialism: Anaesthetics and 12 others Issued:
28 September 2017
· Field Safety Notice - 18 to 22 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 18 to 22 September 2017.
Alert type:
Field safety notice
Medical specialism:
Anaesthetics and 21 others
Issued:
25 September 2017
· All Accu-Chek® Insight insulin pumps – risk of alarm failure
Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 6 others
Issued:
20 September 2017
· All Accu-Chek® Insight insulin pumps – risk of alarm failure
Manufactured by Roche Diabetes Care – the audible and/or vibration alarms might not function, which may lead to hyperglycaemia if the user doesn’t see the notification message on the pump.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 6 others
Issued:
20 September 2017
· Field Safety Notice - 11 to 15 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 11 to 15 September 2017.
Alert type:
Field safety notice
Medical specialism:
Anaesthetics and 21 others
Issued:
18 September 2017
· Lung ventilators: Astral 100, 100SC and 150 – potential power loss due to faulty battery
Manufactured by ResMed – If operated only by the internal battery and this fails, the patient will not be ventilated.
Alert type:
Medical device alert
Medical specialism:
Anaesthetics and 4 others
Issued:
12 September 2017
· Field Safety Notice - 04 to 08 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 2017
Alert type:
Field safety notice
Issued:
11 September 2017
· Field Safety Notice - 04 to 08 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 04 to 08 September 2017
Alert type:
Field safety notice
Issued:
11 September 2017
· Field Safety Notice - 29 August to 1 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 2017
Alert type:
Field safety notice
Medical specialism:
Anaesthetics and 21 others
Issued:
4 September 2017
· Field Safety Notice - 29 August to 1 September 2017
Summary List of field safety notices (FSNs) from medical device manufacturers from 29 August to 1 September 2017
Alert type:
Field safety notice
Medical specialism:
Anaesthetics and 21 others
Issued:
4 September 2017
· Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level
(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
Alert type:
Drug alert
Medical specialism:
Anaesthetics and 21 others
Issued:
4 September 2017
· Error with the barcodes on selected batches of 8 medicinal products by Focus Pharmaceuticals - Distribute to Pharmacy and Wholesaler level
(Focus Pharmaceuticals) Error with the barcodes on selected batches of 8 medicinal products – Class 4 Caution in Use (EL (17)A/08)
Alert type:
Drug alert
Medical specialism:
Anaesthetics and 21 others
Issued:
4 September 2017