MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC MAQUET LINEAR 7.5F; IAB CATHETER

Device Problems Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 07/06/2016

Event Type  Injury  

Event Description

Patient placed on iab support for cardiogenic shock.During use the helium leak alarm sounded.The catheter was visually checked and found to have blood inside the tubing.Iab placed on standby, physician notified.Physician presented and discontinued the iab.

• Brand Name: MAQUET LINEAR 7.5F
• Type of Device: IAB CATHETER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 5832818
• MDR Text Key: 50842743
• Report Number: MW5063732
• 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: 07/25/2016

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/27/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88