MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560BCS1

Device Problem Compatibility Problem (2960)

Patient Problem Cardiac Arrest (1762)

Event Date 09/07/2020

Event Type  Injury  

Manufacturer Narrative

Device was not returned for analysis.The reported complaint of bio-console battery failing was not verified.Service confirmed with customer that the batteries currently being used by facility in this bio-console are not recommended medtronic batteries but other manufacturer batteries that the supplier suggested were suitable.The batteries currently being used do not hold up to being discharged and fail after accidental discharges by the users.Customer has ordered the correct medtronic recommended batteries.Investigation for this event is ongoing.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use the bio-console instrument's batteries failed.The patient was on extra corporeal membrane oxygenation (ecmo) support using this console, during transport to another area of the hospital when the batteries failed, necessitating cpr until ac power could be re-established, approximately 2 minutes.Use of the instrument was continued with no resulting adverse patient effect.This bio-console had ¿after market¿ batteries placed by the hospitals bio-med technicians.These are batteries with known performance issues.These technicians are now opting to replace these batteries with oem medtronic approved batteries obtained from medtronic.

• Brand Name: BIO CONSOLE 560
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10648161
• MDR Text Key: 210379175
• Report Number: 2184009-2020-00065
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: 00613994450463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention