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 12/09/2021

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had condensation in the helium tubing.The end user identified it at one specific location and not running the entire length of the catheter and noted the pump was operating as expected and no alarms are present or have been in the past.End user alleged this was a pump issue and that the catheter would not be the reason this would occur.End user revealed the patient had a leg immobilizer in place and that the catheter tubing was running outside of the device.The getinge support representative reviewed best practices including, making sure there was no dependent loop in the helium tubing, and physical removal of the condensation if necessary via disconnecting from the system and using gravity or suction removal.End user noted this was not necessary, as they would be discontinuing the therapy in the next hour or two.The unit did not alarm for the reported malfunction.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge service territory manager (stm) tried multiple times to contact the customer but only got voicemails and no calls returned.The stm contacted the biomed who had no knowledge of any issues, and as far as they knew the units were working fine.The unit was never taken out of clinical use and no repairs were performed.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

• 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: 16256357
• MDR Text Key: 308843599
• Report Number: 2249723-2023-00612
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• 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: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1