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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 Back to Search Results
Model Number 801763
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer's sales representative installed a new cable.The unit operated to the manufacturer's specifications.The suspect device was returned to the manufacturer for further evaluation.
 
Event Description
Upon receipt of the device, the user reported that the cable pin for the roller pump power cable was broken.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.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
Additional information received that the issue occurred during non-clinical activity.
 
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Brand Name
ADVANCED PERFUSION SYSTEM 1
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key10408729
MDR Text Key203144674
Report Number1828100-2020-00303
Device Sequence Number1
Product Code DTQ
UDI-Device Identifier00886799000656
UDI-Public(01)00886799000656(11)200521
Combination Product (y/n)N
PMA/PMN Number
K172220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number801763
Device Catalogue Number801763
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2020
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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