MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, TYPE B PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 03/23/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had condensation build up in the helium tubing.The arnp called the service desk regarding the malfunction.She stated "they had already switched to a different pump and changed the helium extender tubing and the condensation was visible again." she was instructed to disconnect the extender tubing from the catheter and the pump, apply suction to remove the condensation, then reconnect and resume therapy.The alarm log on the initial pump showed they recently had an autofill failure alarm and an autofill failure-blood detected alarm.No alarms or messages appeared after switching to different pump.This report is for the initial iabp that was replaced.A separate mdr is being submitted for the replacement iabp.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, investigation conclusions), h10.It was reported that the cardiosave intra-aortic balloon pump (iabp) condensation build up in the helium tubing.(b)(6) called regarding condensation build up in the helium tubing.She stated they had already switched to a different pump and changed the helium extender tubing and the condensation was visible again.Instructed her to disconnect the extender tubing from the catheter and the pump, apply suction to remove the condensation, then reconnect and resume therapy.Alarm log on the initial pump showed they recently had an autofill failure alarm and an autofill failure-blood detected alarm.No alarms or messages appeared after switching to different pump.After doing 3 gfe we haven't received any information.As of now, the investigation is closed, if any new information is received future related to part replacement will reopen the complaint and update it.H3 other text : repair service not done.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 16676369
• MDR Text Key: 312721404
• Report Number: 2249723-2023-01767
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 95 KG