Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.09.2017 – 31.10.2017

Опубліковано 01.11.2017 о 00:00


Великобританія

https://www.gov.uk/drugdevicealerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

·                     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

 

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