MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC SENSATION PLUS; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 30000040190017

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 09/24/2015

Event Type  malfunction  

Event Description

The patient had been placed with a intra-aortic balloon pump with alarm going off.The code team stated that there was an air leak in system with blood in tubing.

• Brand Name: SENSATION PLUS
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5179923
• MDR Text Key: 29311946
• Report Number: 5179923
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 30000040190017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BALLOON PUMP
• Patient Age: 77 YR
• Patient Weight: 67