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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 12/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Per log analysis, there are no indications of a problem in the log, the pump worked as designed and configured. The field service representative (fsr), could not verify the reported complaint. The perfusionist said that they were able to restart the pump after they had stopped by pressing pump start button. The fsr tested both pumps which ran without any unexpected stops. The cardioplegia pump is configured to stop when arterial pump stops on the system. Fsr checked operation of both roller pumps, no problems found, roller pump fans operating and connections are okay. The roller pump was found to be operating to terumo specifications and was returned to clinical use. This complaint is related to (b)(4)/ medwatch #1828100-2016-00816. 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
It was reported that during use of the device for a cardiopulmonary bypass procedure, the arterial pump stopped abruptly without any alarm. The customer was able to restart it and continued to use it throughout the case. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: the arterial roller pump stopped twice during cpb without any alert / alarm / error messages to indicate a problem or safety event. Perfusionist stated the pump was able to be quickly re-started each time and the pump was used for the completion of the procedure. The case was completed successfully, without delay and without associated blood loss. There was no harm observed.
 
Manufacturer Narrative
As per field service representative (fsr), the facility's biomed is terumo trained and does the in-house repairs for this hospital. The biomed has already inspected the unit. 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
Corrected information: data log analysis confirmed that the pump stopped twice while running, but does not indicate why it stopped.
 
Manufacturer Narrative
The reported complaint was confirmed by data log analysis. 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. 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 Key6203838
MDR Text Key63622120
Report Number1828100-2016-00817
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2016
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 Received03/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2009
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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