MAUDE Adverse Event Report: DATASCOPE CORP. IABP CATHETER; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2022

Event Type  malfunction  

Event Description

Rn entered room upon hearing iabp alarming.Patient lying in bed, turned to l side, in no apparent distress and conversing with student rn.Alarm message reading "check iabp catheter" and pump in standby mode.Iabp insertion site dry, intact.System checked and was intact.No kinks.Helium line clear.Upon second inspection, blood witnessed entering and flowing down helium line.Patient taken to or for removal.

• Brand Name: IABP CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 14999414
• MDR Text Key: 295772958
• Report Number: 14999414
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female