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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
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THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 102954
Device Problems Pumping Stopped (1503); Electrical Power Problem (2925); Infusion or Flow Problem (2964)
Patient Problem Anxiety (2328)
Event Date 11/29/2019
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 the centrimag began to alarm while supporting a patient.The flows and rpms were noted to be 0.The system was re-started and flows were increased.The site was able to get the patient back to his original settings.During the event, the patient complained of being short of breath.A decision was made to exchange the system to the backup.The centrimag system stopped again as the account was grabbing the backup system.The system was exchanged and flows returned to normal without the patient becoming entirely hemodynamically compromised.The patient's peripheral capillary oxygen saturation dropped to the 70s.The patient was extremely anxious and treated with ativan.The patient returned to baseline.No further information was reported.
 
Event Description
Related manufacturer report number: 2916596-2019-05942.
 
Manufacturer Narrative
Section b5, h4: additional information.Manufacturer's investigation conclusion: the centrimag 1st gen primary console (sn (b)(6)) and motor (sn (b)(6)), used during the reported event of multiple system stops during patient support, were not returned for analysis.Multiple attempts for product requests were made but did not receive a response.As a result, the root cause of the reported event could not be conclusively determined during the investigation.Per reported information, the system was exchanged a back-up system and the patient returned to baseline after the exchange.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
CENTRIMAG 1ST 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 Key9482111
MDR Text Key172235844
Report Number2916596-2019-05943
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number102954
Device Catalogue Number102954
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age37 YR
Patient Weight71
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