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 02/19/2024

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), the cardiosave intra-aortic balloon pump (iabp) had a leak detected.The tidal volume disk was an out of box failure.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d1, d4, d9, g3, g6, h2, h3, h4, h6, h10.The getinge service territory manager (stm) that encountered the issue replaced the tidal volume disk to resolve the issue and the device functioned properly.The part stm installed is brand new and has never been used.All functional and safety checks were performed to meet factory specifications.The failure analysis and testing dept.Received part number 0202-00-0142 with a reported unit failure of a leak.The fat performed a visual inspection and found the part to be in good condition.The fat installed the tidal volume disk in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual.Part failed the leak differential portion during the all manifold test.Fat verified the reported failure but no root cause identified.Retaining the part in the failure analysis and testing department per procedure.

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: 18836022
• MDR Text Key: 336863865
• Report Number: 2249723-2024-00928
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 03/12/2024; 04/30/2024
• Supplement Dates FDA Received: 03/18/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.