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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-90401
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problem Thrombus (2101)
Event Date 02/19/2020
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
It was reported that a newborn patient was implanted on (b)(6) 2020 at (b)(6) center with venous-arterial extracorporeal membrane oxygenation (ecmo) and transferred to (b)(6) university hospital (vfn) hospital. Supporting therapy including thrombo-concentrates and fibrinogen administered. The centrimag (cmag) system was stable on 2900 rpm with flow 290 - 300 mls/min. On 19feb2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line. There was no improvement so the cmag circuit was transferred to a backup centrimag console and motor, but there was no noted improvement. The new cmag circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return). Support therapy was continued, including thrombo-concentrates and fibrinogen administration. On 20feb2020, the clinical team reported sudden decrease of generated flow up to 0 mls/min with stable rpm and a flow below minimum alarm; the return line was clamped and they tried to restart flow by decreasing and increasing rpm with an open return line. There was no improvement, so a new maquet pls ecmo circuit was exchanged with the removal of a small thrombi from the arterial cannulae (return). The patient continued to receive therapy without any event and elective decommissioning of ecmo on (b)(6) 2020. Both the initial cmag system and backup cmag system had to be exchanged due to low flow. This event is also reported under mfr #2916596-2020-01175, mfr# 2916596-2020-01176, mfr#2916596-2020-01177.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
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 Key9785186
MDR Text Key183961153
Report Number2916596-2020-01174
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeEZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number201-90401
Device Lot Number6525865
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 Received06/30/2020
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

Patient Treatment Data
Date Received: 03/04/2020 Patient Sequence Number: 1
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