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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 Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  Injury  
Manufacturer Narrative
Approximate age of device ¿ the centrimag primary console is not a single use device. Approximate age of the device from the manufacturer date is 1 year 5 months. The device was returned for investigation. The evaluation is not yet complete. No further information was provided. Console mfr# 2916596-2019-02528, motor mfr# 2916596-2019-02529, flow probe mfr# 2916596-2019-02712. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was being supported with a ventricular assist device (vad) for acute support. It was reported that the patient was placed on support on (b)(6) 2019 as va (vein-artery) extracorporeal membrane oxygenation (ecmo) with rpm 5500 flow 4. 8 lpm. The patient was converted to vv (vein-vein) ecmo a few hours later and maintained 5500 rpm and 4. 5 lpm. The pump motor started making a louder than normal humming sound, it became physically slightly hot, & rpms. On (b)(6) 2019, system alert s3 alarm came on and dashes appeared on the lpm. Rpm dropped to 3900 rpm and set pump speed not reached alarm m5 appeared. The patient circuit & physical pump was changed at bedside. The customer clamped the circuit and rebooted the system and reinitiated support. The set speed of 5500 dropped to 4900 rpm with dashes on lpm and the system alert s3 appeared. The customer switched to backup system and resumed support. It was determined by biomed & the perfusion department that the centrimag motor was exhausted due to the large amount of resistance induced by a very small outflow cannula size (15 fr), given that the rpm was maxed out at 5500 rpm, and the patient was very large (145 kg). Equipment was exchanged, disposables including centrimag changed, & eventual reduction of rpms and removal from ecmo support. Patient successfully removed from ecmo support on (b)(6) 2019.
 
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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 Key8697157
MDR Text Key148003285
Report Number2916596-2019-02528
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 health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 02/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2020
Device Model Number201-90411
Device Catalogue Number201-90411
Device Lot Number6329351
Was Device Available for Evaluation? Yes
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 Manufactured02/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/13/2019 Patient Sequence Number: 1
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