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 Problems Component Incompatible (1108); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/13/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) that encountered the issue during installation of a new safety disk sn (b)(4), reported that failed several times the membrane leak check portion of the pneumatic interface module leak test.To resolved the issue, the fse installed a new safety disk sn (b)(4) and pim leak test passed.The fse completed the full pm and unit passed all functional and safety test per factory specifications.The iabp was released to the customer and cleared for clinical service.Upon completion of our investigation, a supplemental report will be submitted.The name of the initial reporter has been abbreviated due to field character limit; the full name should read: (b)(6).

Event Description

It was reported that during a new safety disk replacement, performed by a getinge field service engineer (fse), the out of box (oob) safety disk was discovered to be defective.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: b4, d10, g4, g7, h2, h10.The maquet national repair center (nrc) wayne received the defective part for failure investigation.A senior repair technician of the national repair center (nrc) inspected the safety disk, drive side per the cardiosave service manual with no visual damage observed.The technician installed the safety disk into the cardiosave test fixture and tested the disk to factory specifications per procedure and the cardiosave service manual.The membrane differential test results read 9mmhg, the factory specification is 6mmhg.The nrc verified the failure of the disk failing the membrane leak test.The disk failed testing.Sending the safety disk to the cardiosave production department for failure analysis per procedure.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10.The national repair center received the safety disk serial number from the getinge production department.Production verified the failure of the safety disk failing the membrane leak test.The safety disk failed testing.Nrc will retain the disk in the national repair center per procedure.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during a safety disk replacement performed by a getinge field service engineer (fse), the new safety disk consistently failed the membrane leak check portion of the pneumatic interface module leak test.There was 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: 12291010
• MDR Text Key: 265580315
• Report Number: 2249723-2021-01726
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/13/2023

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Initial Date Manufacturer Received: 07/13/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 03/01/2022; 03/13/2023
• Supplement Dates FDA Received: 12/23/2021; 03/29/2022; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1