MAUDE Adverse Event Report: DATASCOPE CORP. MEGA 8FR. 50CC IAB WITH ACCESSORIES, US ONLY; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0296-01U

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

Patient had intra-aortic balloon pump (iabp) for cardiac assist while awaiting heart transplant.The iabp alarmed leak in circuit.Upon assessment, there was blood back to the pump in the helium line.Blood noted in pump system.Health care team decided to wait for iabp removal in the cath lab in the morning.Patient was given boluses of heparin to increase act until cath lab able to take patient for iabp removal.Iabp on standby for 4.5 hours before patient left for cath lab.Patient reported worsening neck and left upper extremity pain.

• Brand Name: MEGA 8FR. 50CC IAB WITH ACCESSORIES, US ONLY
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 10634493
• MDR Text Key: 209995924
• Report Number: 10634493
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0296-01U
• Device Catalogue Number: 0684-00-0296-01U
• 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: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Weight: 121