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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 Problem Erratic or Intermittent Display (1182)
Patient Problem No Patient Involvement (2645)
Event Date 10/25/2018
Event Type  malfunction  
Manufacturer Narrative
The srt observed the display to not turn on when the pump was plugged in.After tapping on the screen, the display operated normally.
 
Event Description
The service repair technician (srt) reported that during routine testing of the device at the service center, the pump had intermittent display operation.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.The service repair technician (srt) will replace the display assembly.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 Name
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8078453
MDR Text Key128054679
Report Number1828100-2018-00593
Device Sequence Number1
Product Code DWB
UDI-Device Identifier00886799000540
UDI-Public(01)00886799000540(11)060823
Combination Product (y/n)N
PMA/PMN Number
K131618
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2018
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
Was the Report Sent to FDA? No
Date Manufacturer Received12/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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