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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC PEDIATRIC FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH EM-TEC PEDIATRIC FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 201-30105
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
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 there was a flow of 0.47 lpm when the centrimag (cmag) system was not turned on and there is no flow.The cmag flow probe was connected to a backup cmag system, and the problem continued.The flow probe was then switched with the a different flow probe with the same console.This resolved the issue.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the flow probe measuring flow when the motor isn¿t running was confirmed.The centrimag flow probe was returned for analysis to the edc and was evaluated.The reported event was able to be reproduced.The flow probe was tested with two different consoles.When the motor was not running, 0 rpm, the flow readings were always between 0.40 lpm ¿ 0.48 lpm.The flow probe is out of calibrations and will be scrapped.The root cause for the reported event was conclusively determined to be due to the flow probe needing calibration.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
EM-TEC PEDIATRIC FLOW PROBE
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ  CH-8005
MDR Report Key9713050
MDR Text Key180194600
Report Number2916596-2020-00838
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
PMA/PMN Number
K020271
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number201-30105
Device Catalogue Number201-30105
Device Lot Number6480352
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/27/2020
Initial Date FDA Received02/14/2020
Supplement Dates Manufacturer Received05/29/2020
Supplement Dates FDA Received06/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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