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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

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THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 102953
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/29/2019
Event Type  Death  
Event Description
It was reported that the patient passed away due to multi-system organ failure.
 
Manufacturer Narrative
Section a: multiple attempts were made to obtain additional information from the customer regarding the event (including gender and weight); however, no additional information was provided.Manufacturer's investigation conclusion: a direct correlation between the device and the reported patient outcome could not be determined through this evaluation.Multiple requests for additional information were sent to the customer; however, no response has been received at this time.The centrimag blood pump instructions for use (ifu) lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ in addition, this ifu lists multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) as adverse events that may be associated with the centrimag circulatory support system.Review of the device history record (dhr) for the centrimag blood pump (dhr cm pump (b)(6) revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists death as an adverse event that may be associated with the centrimag circulatory support system under ¿adverse events.¿ in addition, this ifu lists multiple types of organ failure and dysfunction (hepatic dysfunction, renal dysfunction, respiratory failure, and right heart failure) as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #1: carefully read all warnings, precautions, manuals, and instructions for use for this and all related thoratec extracorporeal devices prior to use.Failure to read and follow all instruction, or failure to observe all stated warnings, could cause serious injury or death to the patient.Ifu warming #10: frequent patient and device monitoring is recommended.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG BLOOD PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
MDR Report Key11397870
MDR Text Key234205804
Report Number3003306248-2021-00554
Device Sequence Number1
Product Code KFM
UDI-Device Identifier07640135140627
UDI-Public07640135140627
Combination Product (y/n)N
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/11/2021
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 Lay User/Patient
Device Expiration Date01/31/2022
Device Model Number102953
Device Catalogue Number102953
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/02/2021
Initial Date FDA Received03/02/2021
Supplement Dates Manufacturer Received04/29/2021
Supplement Dates FDA Received05/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age45 YR
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