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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 L201-90411
Device Problems Mechanical Problem (1384); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2019
Event Type  Injury  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The site reported a centrimag presenting with alarm of "battery failure." the account changed pump and console.The locking screw were reported to not be properly threaded on back of pump.The patient was switched to a second back up pump.The centrimag pump was clamped twice prior to switch.The patient tolerated the equipment swap well.No further information was reported.
 
Manufacturer Narrative
Manufacturer"s investigator conclusion: the reported event of a battery failure was not confirmed.The centrimag 2nd generation primary console was not returned for analysis.No log files or additional information regarding the console was received.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.
 
Manufacturer Narrative
User facility report: (b)(4) was received (b)(6) 2019.Section a: multiple attempts were made to obtain additional information from the customer regarding patient identifier and weight; however, no additional information was provided.Section e4, f, h4, h5, h8: correction.
 
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Brand Name
CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ  CH-8005
MDR Report Key9369088
MDR Text Key167835862
Report Number2916596-2019-05341
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 health professional
Type of Report Initial,Followup,Followup,Followup
Report Date 10/01/2019,03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberL201-90411
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Other
Date Report to Manufacturer10/01/2019
Initial Date Manufacturer Received 11/05/2019
Initial Date FDA Received11/25/2019
Supplement Dates Manufacturer Received02/10/2020
03/03/2020
03/25/2020
Supplement Dates FDA Received02/27/2020
03/23/2020
03/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age20 YR
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