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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90411
Device Problem Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2018
Event Type  malfunction  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
The patient was supported by an extracorporeal circulatory support device on (b)(6) 2018. It was reported a battery maintenance alarm was observed on the centrimag console. The console was exchanged out and battery maintenance was to be performed at the hospital. There was no delay in the procedure or adverse impact to the patient. As of (b)(5) 018, the patient was still supported by an extracorporeal circulatory support device. No additional information was provided.
 
Manufacturer Narrative
The reported event could not be confirmed because the centrimag primary console was not returned for evaluation. Additionally, a root cause for the event could not conclusively be determined. A review of the device history records, including sterilization and packaging documentation, found no deviations from manufacturing specifications. No further information was provided. The manufacturer is closing the file on this event.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
MDR Report Key7729307
MDR Text Key115361114
Report Number2916596-2018-03042
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No

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