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: TELEFLEX INCORPORATED IABP 40MLS BS20742; 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 IABP 40MLS BS20742; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number BS20742
Device Problems Contamination (1120); Material Rupture (1546); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/05/2022
Event Type  malfunction  
Event Description
Intensive care unit (icu) patient with teleflex intra-aortic balloon pump (iabp).The iabp alarmed, with helium loss and blood noted in tubing, due to balloon rapture.Iabp stopped, physician notified, patient returned to cath lab and had a new iabp inserted.Patient remained stable on new iabp.Teleflex representative notified, to evaluate/examine the balloon defect.
 
Event Description
Intensive care unit (icu) patient with teleflex intra-aortic balloon pump (iabp).The iabp alarmed, with helium loss and blood noted in tubing, due to balloon rapture.Iabp stopped, physician notified, patient returned to cath lab and had a new iabp inserted.Patient remained stable on new iabp.Teleflex representative notified, to evaluate/examine the balloon defect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IABP 40MLS BS20742
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key15893285
MDR Text Key304626665
Report Number15893285
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 Risk Manager
Type of Report Initial,Followup
Report Date 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberBS20742
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/08/2022
Event Location Hospital
Date Report to Manufacturer12/01/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/01/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age31025 DA
Patient SexMale
Patient Weight72 KG
Patient EthnicityHispanic
-
-