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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1

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TERUMO CARDIOVASCULAR SYSTEM CORP. TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1 Back to Search Results
Model Number 816571
Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 09/23/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during use of the device for a cardiopulmonary bypass procedure, the perfusionist (ccp) received a belt slip error on the roller pump. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient. Per clinical review: per email communication with the perfusionist (ccp), the ccp reported during cardioplegia delivery (4:1 set), an alarm with message occurred (beltslip) and the ccp claims the cardioplegia pump stopped. She simply re-started the pump in a few seconds and no other issues occured. I sent her the attached email to inform her of messages that can occur when the pump is overoccluded (beltslip for example) and new 1. 40 software is installed. She was not aware of this potential behavior, with 1. 40 software pumps. She now knows, that roller occlusion may need to be adjusted if messaging (like beltslip) occurs in the future. This pump continues to be used and has been used in other cases, since this event. The case was completed successfully, without delay and without associated blood loss. There was no harm observed.
 
Manufacturer Narrative
The field service representative (fsr) was dispatched to the user facility. The fsr tried duplicating a belt slip using 1/4" and 3/8" tubing, but did not receive a belt slip error. In using the pump jam preventive maintenance (pm) fixture the fsr could get a pump jam message as normal but not reproduce the belt slip error message. The fsr completed the pm on the device and the device 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.
 
Manufacturer Narrative
The reported complaint was not verifiable. 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 NameTERUMO ADVANCED PERFUSION SYSTEM 1
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP, SYSTEM 1
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7347416074
MDR Report Key6035292
MDR Text Key57805993
Report Number1828100-2016-00686
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
Report Date 01/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/17/2016
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? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2010
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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