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 10/04/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit had excessive condensation buildup in catheter.There was no patient harm reported.Related to complaint (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Updated field: b4, d9, e1-(site country), 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) had excessive condensation.There was no adverse event reported a getinge fse was dispatched to evaluate the unit.Unit reported to have condensate buildup in catheter during patient use.No patient harm reported.Pump was removed from service.Inspected pim, and performed pim leak test to determine if any malfunction occurred.Leak tests passed and issue could not be duplicated.Performed functional testing and safety checks.Unit passed all functional and safety tests per factory specifications, returned unit to customer and cleared for clinical use.

Event Description

N/a.

• 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: 15598248
• MDR Text Key: 304715973
• Report Number: 2249723-2022-02643
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1