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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC

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TERUMO CARDIOVASCULAR SYSTEMS CORP. LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC Back to Search Results
Model Number 816571
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Per sales representative, hospital had two visits from field service but the issue still re-occurred. They are asking if they can ship the entire system 1 for repair. Additional diligence confirmed the pump stops occurred during priming and after the procedure. This complaint is related to (b)(4)/ medwatch #1828100-2017-00013. This complaint is related to (b)(4)/ medwatch #1828100-2017-00015.
 
Event Description
It was reported that during priming of the device for a cardiopulmonary bypass procedure, the user facility reported that the large roller pump stopped. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient reported. Per clinical review, the pump had stopped earlier in the day when a perfusion circuit was being primed and prepared for cardiopulmonary bypass. It stopped, without user intervention, and a service pump message was posted on the local pump display. It could be re-started with local pump controls, but the perfusionist elected to not use the pump during the procedure and totally new perfusion system was used during the procedure. After the procedure was completed, the perfusionist was trying to duplicate the pump stop, with service pump messaging. The perfusionist started the pump and ran the pump at about 4-5 l / min and the pump did stop and the service pump message was posted on the local display. The perfusionist was able to duplicate the pump stop as observed during prime. This pump was not used during the procedure.
 
Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) could not duplicate the reported complaint. He operated the pump for approximately 180 hours with no pump jam and no "service pump" message observed. Per data log analysis, no actual indications of a problem are found in the log files. The large roller pump art did stop three times, but there is currently no way to tell from the log if service pump was displayed. The art pump only had 1 configured safety connection to stop on air bubble detection.
 
Manufacturer Narrative
The reported complaint was confirmed via data log analysis. 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 NameLARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP FOR ADVANC
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 Key6234443
MDR Text Key64606585
Report Number1828100-2017-00015
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153376
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/30/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number816571
Device Catalogue Number816571
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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