MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY MAQUET; INTRA-AORTIC BALLOON CATHETER

Lot Number (21) CH256995E7

Device Problems Backflow (1064); Device Contamination with Body Fluid (2317)

Patient Problem Pain (1994)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Pt.Waiting on a heart transplant.Bedside rn noticed iabp waveform changed, flushed line and waveform returned momentarily.Waveform again changed and when rn assessed the helium tubing, she found condensation and small specks of blood in the line.Ccu team was called to the bedside and at this time the amount of blood in the tubing increased.Iabp was put in standby and helium tubing clamped.Pt reporting pain.Ct surgery team came to assess pt.Balloon was removed.Repair r axillary artery.

• Brand Name: MAQUET
• Type of Device: INTRA-AORTIC BALLOON CATHETER
• Manufacturer (Section D): MAQUET CARDIOPULMONARY; 45 barbour pond dr; wayne NJ 07470
• MDR Report Key: 9255352
• MDR Text Key: 164282078
• Report Number: 9255352
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: (21) CH256995E7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 69