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U.S. Department of Health and Human Services

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

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP Back to Search Results
Model Number 801041
Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 10/05/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Per the service repair technician (srt), there was no tubing or obstruction in the roller pump. The optical switch was replaced. The unit operates to the manufacturer's specifications. 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
The service repair technician (srt) reported that during routine testing of the device at the service center, the pump repeatedly stopped and displayed a 'pump jam error' message multiple times. There was no patient involvement.
 
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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
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6984853
MDR Text Key91356021
Report Number1828100-2017-00492
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 10/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number801041
Device Catalogue Number801041
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 Received10/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2003
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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