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 6382
Device Problems Detachment of Device or Device Component (2907); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
The fsr replaced the flow sensor.The unit operated to the manufacturer's specifications.
 
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the flow sensor latch was missing a pin and unable to latch.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.
 
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 Key11672143
MDR Text Key252015477
Report Number1828100-2021-00136
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
Type of Report Initial,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Was the Report Sent to FDA? No
Date Manufacturer Received05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-