MAUDE Adverse Event Report: MAQUET / DATASCOPE CORP. IAB CATHETER SENSATION 7 FR.; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Lot Number 3000115469

Device Problem Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

Balloon pump began to alarm, message read 'catheter restriction'; pt position adjusted, would not restart, continued to alarm going between balloon will not fill; catheter restriction and gas gain.Lines were checked, patient position including lying flat and on left side.Another balloon pump machine was hooked up with the same alarms.Fda safety report id# (b)(4).

• Brand Name: IAB CATHETER SENSATION 7 FR.
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET / DATASCOPE CORP.
• MDR Report Key: 10337978
• MDR Text Key: 201053383
• Report Number: MW5095762
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/24/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3000115469
• Was Device Available for Evaluation?: Yes
• 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