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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 Decreased Pump Speed (1500)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
No patient information was provided. No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is complete.
 
Event Description
Related manufacturer report numbers: 2916596-2021-04342, 2916596-2021-04343, and 2916596-2021-04344. It was reported that the patient was placed on venovenous (vv) extracorporeal membrane oxygenation (ecmo) with centrimag on (b)(6)2021. The centrimag settings were 5400 revolutions per minute (rpm) and 6. 86 liters per minute (lpm). There was a circuit exchange to a different console on (b)(6) 2021. The centrimag settings were 5400 rpm and 6. 93 lpm. The customer site reported that they were unable to get to 5500 rpm with the patient on two different consoles. Two circuit exchanges and two different centrimags were able to get the patient to 5450 rpm highest. On (b)(6) 2021 the patient was decannulated and the system was available for evaluation. The centrimag console and centrimag motor were placed on the hospital's primed circuit and 5500 rpms was achieved for over two hours. The hospital site could not reproduce the event. There were no alarms through the duration of the run.
 
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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 CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key12263649
MDR Text Key264783918
Report Number2916596-2021-04345
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131179
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-90411
Device Catalogue Number201-90411
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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