MAUDE Adverse Event Report: MAQUET/ DATASCOPE CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP

Model Number 0998-00-0800-53

Device Problems Inadequate Instructions for Healthcare Professional (1319); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 03/01/2018

Event Type  Injury  

Event Description

Balloon pump will not operate with a 50cc balloon at or greater than a specific altitude.A hospital at 6800 ft is unable to use the 50cc balloon.Pump will give calibration errors and not allow the user to proceed.However, the pump will operate with a 40cc balloon at that same altitude.Operating instructions do not provide any information on steps necessary to operate at higher altitudes or properly transport using the pump between facilities with significantly different altitudes.

• Brand Name: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): MAQUET/ DATASCOPE
• MDR Report Key: 7521621
• MDR Text Key: 108621620
• Report Number: MW5077265
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention