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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 Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/03/2019
Event Type  Injury  
Manufacturer Narrative
This event is also reported under mfr #2916596-2019-04393. 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 patient was being transferred back to patient bed. When moving the equipment back to patient bed, the nurse hears and notices alarm with 0. 0 lpm flows on the console. Different nurses checked connections for centrimag (cmag) flow probe, motor, and disposable housing was proper. Felt and visualized the motor and noticed no movement. Dark blood was observed in extracorporeal membrane oxygenation (ecmo) lines. The motor and console was immediately switched to a 2nd generation equipment set. Flow was reestablished, and the patient was not compromised. The second down incident was less than 5 minutes. A perfusionist tested the exchanged equipment. "pump not inserted: m3" and "system alert: s3" was observed when testing the set. Same alarms appeared when the motor was interchanged with another working motor even when turned on and off.
 
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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 CA CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9104731
MDR Text Key161450045
Report Number2916596-2019-04391
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model NumberL201-90411
Device Lot Number6329351
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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