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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30100
Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2020
Event Type  Injury  
Manufacturer Narrative
The motor associated with this event is being reported under mfr # 2916596-2020-00219. 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 implanted with centrimag and a sudden "flow below minimum" alarm occurred without any manipulation of the patient or system. At the same time was noted on the rpm display. The clinical team noted that there was no blood flow through the pump and the pump had stopped. The primary console, motor, and flow probe were immediately changed and blood flow was restored. The patient had adequate oxygenation and was hemodynamically stable during the event.
 
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Brand NamePRIM CONS 1ST GEN, STANDALONE
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 Key9678356
MDR Text Key178097525
Report Number2916596-2020-00705
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K093832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number201-30100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/06/2020 Patient Sequence Number: 1
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