Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 Back to Search Results
Model Number 801764
Device Problem Failure to Run on Battery (1466)
Patient Problem No Patient Involvement (2645)
Event Date 09/30/2019
Event Type  malfunction  
Manufacturer Narrative
Per the distributor, the heart lung machine (hlm) is now working fine, they had found that one of the batteries was not working properly.
 
Event Description
It was reported that during routine testing of the device, the unit was not switching over to battery in the case of alternating current (ac) power failure.There was no patient involvement.
 
Manufacturer Narrative
Per the manufacturer's subsidiary, the replaced battery was disposed of so an evaluation could not be completed.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9234164
MDR Text Key168847937
Report Number1828100-2019-00563
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number801764
Device Catalogue Number801764
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-