• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED AC3 OPTIMUS IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

  • 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
 

TELEFLEX INCORPORATED AC3 OPTIMUS IABP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Device Problems Defective Component (2292); Blocked Connection (2888); Calibration Problem (2890)
Patient Problem Insufficient Information (4580)
Event Date 03/16/2021
Event Type  malfunction  
Event Description
When it was determined the surgeon wanted to insert an intra aortic balloon (iab) catheter in the patient, an intra aortic balloon pump (iabp) was brought into the or. When the perfusionist tried to attach the fiber optic calibration device of the iab catheter it would not lock into the iabp as expected. Further more the iabp would not recognize the calibration device and initiate the fiber optic calibration process. At this point another perfusionist went out to retrieve a second iabp. When the iab fiberoptic device was inserted into the second iabp it would not lock into place once again. At this point it was decided that the original iabp would be used and there would be no fiber optic pressure capability. Upon further inspection by the perfusionist, it appeared that the fiber optic calibration receptacles might have been faulty on both iabp's. Both the manufacturer's rep and biomedical engineering were notified of the problem and made aware that there was potentially two devices in question. The device serial numbers were communicated to biomedical engineering.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAC3 OPTIMUS IABP
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key11776264
MDR Text Key249027413
Report Number11776264
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2021
Event Location Hospital
Date Report to Manufacturer05/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-