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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 9437
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/28/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The supplier company is using the device to check air bubble detector (abd) units during production. They need a replacement delphin pump. On 11-may-2016 per manufacturer service manager: unfortunately we cannot ship any to the customer at this time.
 
Event Description
It was reported that during the use of the device for a non-clinical activity, the customer was starting their production line back up and when they went to hook up the delphin pump, it would not function properly. The motor would not start every time, however if the pump was moved, the motor would usually turn back on. There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was not confirmed. Diligence attempts were unsuccessful to receive the part for evaluation. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand NameSARNS CENTRIFUGAL SYSTEM
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5672577
MDR Text Key45881802
Report Number1828100-2016-00366
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,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number9437
Device Catalogue Number9437
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2016
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 Reuse

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