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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS CENTRIFUGAL SYSTEM; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 6382
Device Problem Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was confirmed.During laboratory evaluation, the pst observed that the metal on the plug was bent to the point where the connector could not be plugged in.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
The product surveillance technician (pst) reported that during laboratory evaluation of the device at the service center, the flow sensor plug was distorted.There was no patient involvement.
 
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Brand Name
SARNS CENTRIFUGAL SYSTEM
Type of Device
CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer (Section G)
SAME
Manufacturer Contact
douglas patton
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key10035040
MDR Text Key190314906
Report Number1828100-2020-00190
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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