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 Component Incompatible (1108)

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 defective (oob) safety disk with sn # (b)(4).To resolved the problem, the fse replaced with a new (oob) safety disk.In addition, the fse reported that a 2nd new safety disk consistently failed several times the membrane leak check portion of the pneumatic interface module leak test.A new complaint was created to document the 2nd new safety disk failure (reported in related complaint # (b)(4).Subsequently, the fse informed that a full pm was completed.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 in has been abbreviated due to field character limit; the full name should read: (b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.

Event Description

It was reported that during scheduled service performed by a getinge field service engineer (fse), the safety disk was due in the intra-aortic balloon pump (iabp).When the new safety disk was replaced, the membrane leak test portion of the pneumatic interface module leak test failed due to a safety disk (oob) failure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

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 8mmhg, 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.

Event Description

N/a.

Manufacturer Narrative

The safety disk, drive side was received at the maquet national repair center (nrc).A technician of the maquet national repair center (nrc) inspected the safety disk, drive side per the cardiosave service manual, with no visual damage observed.The techniciam installed the safety disk into the cardiosave test fixture and tested the disk to factory specifications per procedure and the cardiosave service.The membrane differential test results read 8mmhg, the factory specification is 6mmhg.The technician verified the failure of the disk failing the membrane leak test.The disk failed testing.The safety disk was sent to the cardiosave production department for failure analysis per procedure.The national repair center received the safety disk,drive side from the production department.Production verified the failure of the disk failing the membrane differential leak test with a result of 10mmhg.The factory specification is +- 6mmhg.The disk failed testing.The disk will be retained in the nrc per procedure.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

The getinge field service engineer (fse) that encountered the issue replaced the safety disk (0202-00-0140).Post installation of the second safety disk, the pim leak test passed.The fse performed a complete preventive maintenance (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.

• 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: 12289282
• MDR Text Key: 265437171
• Report Number: 2249723-2021-01749
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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; 02/07/2022; 03/13/2023
• Supplement Dates FDA Received: 12/23/2021; 03/08/2022; 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