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 Leak/Splash (1354)

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) cardiosave intra-aortic balloon pump (iabp) drive manifold leak test failed.There was no patient involvement reported.

Manufacturer Narrative

The stm that encountered the issue replaced the drive manifold.The fse performed a complete pm with full calibration.The unit passed all functional and safety tests per factory specifications.The iabp was returned to the customer and cleared for clinical use.The maquet failure analysis and testing (fat) department received drive manifold assy.With a reported unit failure message of drive manifold leaking.Performed visual inspection of this part received and part looks to be in good condition.Installed the drive manifold assy.Into the cardiosave test fixture and tested to the factory specifications per the cardiosave service manual.The fat performed all manifold tests and found vacuum leak diff.Pres.Failed with the result of 35 mmhg and pressure leak diff.Prs.Failed with the result of -63 mmhg.The factory specification is for vacuum leak diff.Pre.+-25mmhg and pressure leak diff.Pre.+-55mmhg.The failure analysis and testing department verified the failure message of leaking drive manifold.Drive manifold assy, failed testing.Retaining drive manifold assy, in the fat dept.As per procedure.

• 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: 18418574
• MDR Text Key: 331600501
• Report Number: 2249723-2023-05554
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1