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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 816570
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
The field service representative (fsr) was unable to verify the reported complaint.He performed visual inspections, mechanical and electrical testing and found no issues.The unit operated within manufacturer's specifications.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the roller pump would not start up or respond.It could not be controlled manually or by the central control monitor (ccm).As a result, an alternate device was employed.There was no reported delay.No other details regarding the nature of this event were provided.
 
Manufacturer Narrative
The reported complaint could not be confirmed.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
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 Key9732062
MDR Text Key195112675
Report Number1828100-2020-00073
Device Sequence Number1
Product Code DTQ
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,health
Type of Report Initial,Followup
Report Date 05/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number816570
Device Catalogue Number816570
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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