MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS / DATA SCOPE CORP. INTRA ARTERIAL BALLOON PUMP CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS300

Device Problem Material Rupture (1546)

Patient Problem Chest Pain (1776)

Event Date 08/16/2018

Event Type  malfunction  

Event Description

Pt underwent subclavian placement of an intraarterial balloon pump (iabp).The next day, the "check iabp catheter" alarmed occasionally when pt sitting with head down slumping, and stopped alarming when sitting up straight.When getting back to bed, the pt complained of pain in chest with movement, but went away once straightened out.The nurse noticed blood in the tubing.The pt was emergently taken to the cath-lab for replacement of the iabp catheter.The iabp catheter was found to have ruptured.A new iabp console was used.

• Brand Name: INTRA ARTERIAL BALLOON PUMP CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): MAQUET MEDICAL SYSTEMS / DATA SCOPE CORP.
• MDR Report Key: 7809379
• MDR Text Key: 118206837
• Report Number: MW5079337
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS300
• 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 Age: 60 YR
• Patient Weight: 98