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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 201-30300
Device Problems Pumping Stopped (1503); Vibration (1674); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2019
Event Type  Injury  
Manufacturer Narrative
Approximate age of the device is 3 days. The patient remains on centrimag support with no further issues reported.
 
Event Description
It was reported that the patient was on 3700 rpms and flow was 3. 4 lpm and stable. At 12:45am the centrimag motor started to make a humming noise and clinician placed her hand on the motor and felt a much stronger vibration than normal. Alarm flow below minimum sounded and then the lpm appeared to be dashes. The rpm dropped suddenly from 3700 to 3200 rpm. The console screen blanked out even though the monitor still was on showing rpm at 3200 and dashes on lpm. Clinician attempted to raised the rpms on monitor with no response. The nurse called out for assistance and then initiated an emergency system exchange to the backup system. The total exchange time from initial alarm to reinitiating of flow to the backup system took 45 seconds.
 
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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 95488
7818528390
MDR Report Key8647138
MDR Text Key146273797
Report Number2916596-2019-02514
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
Type of Report Initial,Followup,Followup
Report Date 02/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Catalogue Number201-30300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/29/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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