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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER PUM

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER PUM Back to Search Results
Model Number 16402
Device Problem Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2016
Event Type  malfunction  
Manufacturer Narrative
The reported complaint was not verifiable. Per the user facility biomedical (biomed) employee, the assigned biomed for this complaint was on leave and they cannot access the order confirmation number. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
(b)(4). The user facility's biomed is a terumo trained personnel and will try to repair the pump.
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the knob stops when turning at 15 rpm. The product was not changed out. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review, the pump was being used as a vent pump and when the speed was increased to or past 15 rpm or decreased down towards 15 rpm, the pump would hesitate but the speed knob could be increased or decreased and the pump speed would change after the hesitation. The pump was able to be used to complete the procedure. The pump was removed from service after the case was completed. The case was completed successfully, without delay and without associated blood loss. It was not changed out during the actual procedure. There was no harm observed.
 
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Brand NameSARNS 8000 UNIVERSAL ROLLER PUMP
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE¿SARNS 8000 UNIVERSAL ROLLER PUM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7347416074
MDR Report Key6215546
MDR Text Key212250564
Report Number1828100-2016-00834
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number16402
Device Catalogue Number16402
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 Received07/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/1999
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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