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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE Back to Search Results
Model Number 102956
Device Problems Pumping Stopped (1503); Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/04/2019
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
It was reported that the devices revolutions were programmed and the motor cable was moved by mistake.This caused an immediate m2 alarm to appear on the display even though the motor was still connected, which caused the revolutions to drop to 0 and the pump to stop.The alarms were quickly silenced and the revolution reprogrammed.However, the alarm reappeared and seconds later an s3 alert was shown.The centrimag motor was replaced by the backup and no failures presented again.There were no adverse consequences with the patient.
 
Manufacturer Narrative
Manufacturer's investigation conclusions: the reported event of a m2 and s3 alarm was confirmed.The centrimag motor (serial #: (b)(6)) was returned for analysis to ppe.The motor underwent resistance and insulation testing on the motor cable.An increase in resistance was noted when the bend relief on the connector end was manipulated.The increased resistance was seen in some lines of the cable.The motor passed insulation testing.The motor was connected to a mock loop and the reported m2 and s3 alerts were present.The motor was forwarded to the service depot.The motor was returned to the service depot and was evaluated and tested under work order (b)(4).The motor was tested with a test console and flow probe.The motor was manipulated at the bend relief and a m2 error activated.The motor was consequently scrapped.The root cause for the reported alarms was conclusively determined to be due to damage to the motor cable.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG MOTOR, US
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 Key9234279
MDR Text Key163746563
Report Number2916596-2019-05022
Device Sequence Number1
Product Code KFM
UDI-Device Identifier07640135140078
UDI-Public7640135140078
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Recall
Type of Report Initial,Followup
Report Date 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number102956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberFA-Q318-MCS-1
Patient Sequence Number1
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