MAUDE Adverse Event Report: MAQUET BALLOON PUMP; CARDIOSAVE

Model Number 0998-00-0800-53

Device Problems Contamination (1120); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 03/07/2021

Event Type  Death  

Event Description

Blood was noted to be collecting in tubing connected to pt and iabp device.Balloon serial number was (b)(4).

• Brand Name: BALLOON PUMP
• Type of Device: CARDIOSAVE
• Manufacturer (Section D): MAQUET ; drive wayne NJ 07470
• MDR Report Key: 11626945
• MDR Text Key: 244273078
• Report Number: 11626945
• Device Sequence Number: 1
• Product Code: DSP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• 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: 03/18/2021
• Device Age: 6 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR