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

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

Per report, iabp began to alarm check circuit around 6pm.Patient line checked.Patient has fluid(non-blood) in the iabp helium circuit.Helium circuit and console changed.Patient vitals stable with no signs of distress.Md to the bedside per report.Fellow and attending notified.At this time patient is just being monitored for any complications with the intent to potentially replace line in the morning.

• Brand Name: IABP CATHETER
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• MDR Report Key: 15093354
• MDR Text Key: 296476072
• Report Number: 15093354
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male