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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 APS1

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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 APS1 Back to Search Results
Model Number 801041
Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/31/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). This complaint is related to (b)(4) / medwatch #1828100-2017-00033 and medwatch #1828100-2017-00034.
 
Event Description
It was reported that during pre-cardiopulmonary bypass procedure, the pump stopped. A service error message was displayed on the screen. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss or adverse consequences to the patient.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
Manufacturer Narrative
During laboratory analysis, the product surveillance technician (pst) was not able to duplicate the complaint. The pst performed multiple tests and observed no pump stops, no decreasing flow, and no service pump error messages while operating pump at optimal occlusion settings. When pump was extremely over occluded with 1. 4 software, loaded pump can randomly decrease the flow rate and produce service pump error messages. 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
The reported complaint was confirmed via data log analysis. Per data log analysis, only the pump log was provided. On (b)(6) 2016, a perfusion screen was opened at 10:13:42. The pump was started at 13:26:16 and stopped 3 times at 13:28:10, 13:30:14, and 13:30:41. There were no indication in the log to indicate why the pump stopped. The perfusion screen was exited at 13:30:48. The system was power cycled twice, each time opening a perfusion screen. There were several pump stopped but none associated with a trigger or error. There is no way to tell from the log if "service pump" was displayed. The service repair technician (srt) performed functional test and observed customer pump to operate as intended. Roller pump operated to the manufacturer's specification. 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 APS1
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 Key6277669
MDR Text Key66007850
Report Number1828100-2017-00032
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801041
Device Catalogue Number801041
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/24/2007
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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