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Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console… — recall 62386

Health Canada — Medical Devices · Canada · 2022-02-08 · Type II

As described by Health Canada — Medical Devices: Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (2021-03-05)

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Agency
Health Canada — Medical Devices
Recall identifier
62386
Date of alert
2022-02-08
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: Revision D of recall: As a result of eight (8) customer complaints since revision A of this recall, a malfunction with the system controller module used in the Bio-Console 560 was identified. The malfunction is a result of the DC-DC converter and D88 diode failure because of a transient voltage spike in system controller module. This transient voltage spike has the potential to cause dielectric breakdown of the DC-DC converter front-end circuitry resulting in catastrophic failure/excessive current. Through 03-Jan-2022, this issue has resulted in eight (8) complaint occurrences (prior to use) where the instrument or user interface (UI) was not working (blank UI screen), error code 41 and/or smoking/smoking smell prior to use when the device was powered on. No adverse patient effects occurred as a result of these occurrences. Medtronic began using the affected PN in February 2021 to manufacture, service and implement part replacement per Technical Service Update (TSU) MOD0204. All Bio-Console 560 instruments manufactured (January & February 2021) with or had a system controller module installed with the affected system controller are affected by this issue. Additionally, system controller modules that are available for installation by the field service technicians for revision A of this recall are affected. Recall start date: 2022-01-18
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/medtronic-bio-console-560-extr

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