MAUDE Adverse Event Report: TELEFLEX LLC (NADC 2) INTRA-AORTIC BALLOON PUMP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 1852100024

Device Problem Increase in Pressure (1491)

Patient Problem Insufficient Information (4580)

Event Date 08/12/2021

Event Type  malfunction  

Event Description

Right femoral intra-aortic balloon pump alarming high pressures and blood noted in helium line.Fda safety report id # (b)(4).

• Brand Name: INTRA-AORTIC BALLOON PUMP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX LLC (NADC 2)
• MDR Report Key: 12438695
• MDR Text Key: 270670521
• Report Number: MW5103755
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2021

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 Operator: No Information
• Device Lot Number: 1852100024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR