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 Failure to Zero (1683)

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

Event Date 02/09/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) unit was not zeroing the blood pressure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Testing of actual/suspected device: a (b)(4) field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp) unit and was able to reproduce the reported issue.The fse determined that the front end board was damaged and making intermittent contact with the trainer plug.To fix the issue, the fse replaced the pcb, front end, rohs, reloaded b.17 software to ensure that all boards were up to date and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the end user switched to a back-up cardiosave intra-aortic balloon pump (iabp) unit which did not zero the blood pressure, and would only show dashes.Specifically, the end user reported that the when connecting the pressure cable, the iabp unit did not register the presence of the pressure cable, and as a result, the end user was able to zero the transducer.However, the end user also reported that the iabp unit was functioning normally throughout this process and timing on the ecg trigger.Since the end user was unsuccessful in obtaining the pressure monitoring, it was decided to switch the patient back to the original iabp controller.The patient was safely transitioned and the iabp re-started at 1:1 timing, without incident.Another back-up iabp unit was obtained in case of recurrence.Of note, it was further reported that the pressure issue was tested and verified that the pressure input was not working.No patient harm, serious injury or adverse event was reported.

Event Description

It was reported that prior to use the cardiosave intra-aortic balloon pump (iabp) unit was not zeroing the blood pressure.There was no patient involvement.

Event Description

N/a.

Manufacturer Narrative

Getinge field service engineer (fse) customer reported unit blood pressure wouldn't zero out on display, only showing dashes.No patient involvement.Rep inspected blood pressure connection on front end board and found it to be damaged and making intermittent contact with trainer plug.Replaced front end board and recalibrated unit.Reloaded b.17 software to ensure all boards up to date.Performed full calibration, functional testing and safety checks.Unit passed all functional and safety tests per factory specifications, returned unit to customer and cleared for clinical use no patient involvement.

• 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: 13694342
• MDR Text Key: 290167757
• Report Number: 2249723-2022-00477
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB CATHETER.; N/A.
• Patient Age: 52 YR
• Patient Sex: Male