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 Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), the safety on the cardiosave intra-aortic balloon pump (iabp) failed the membrane test of the pim section of the all manifold test.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

During a preventative maintenance (pm) service, the getinge field service engineer replaced the safety disk for its 4 year interval and the safety disk failed the membrane test of the pim section of the all manifold test.To fix the issue the fse replaced the safety disk which corrected the issue, then performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per 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.(b)(6).The initial reporter named is a getinge employee who has different contact details from that of the event site.A contact person at the event site is (b)(6).

Manufacturer Narrative

The aware date reported in the initial report was submitted incorrectly.The aware date should read: 2022-01-11.The following investigation of the safety disk was performed at getinge's national repair center(nrc) per the cardiosave service manual with no visual damage observed.The nrc installed the safety disk into the cardiosave test fixture and tested the safety disk to factory specifications per procedure and the cardiosave service manual.The nrc could not verify the failure of the safety disk failing the membrane test, of the pim section of the all manifold test.The safety disk passed the all manifold test, with no problem found.The safety disk passed testing.The nrc will send the safety disk to the production department per procedure.A supplemental report will be submitted when additional information is provided.

Manufacturer Narrative

Updated fields: b4,e1(site country), (type of investigation, investigation findings, investigation conclusions).The defective components were received for further investigation.The national repair center installed the safety disk into the cardiosave test fixture and tested the safety disk to factory specifications per procedure and the cardiosave service manual.The nrc could not verify the failure of the safety disk failing the membrane test, of the pim section of the all manifold test.The safety disk passed the all manifold test, with no problem found.The safety disk passed testing.The defective components were received for further investigation.The investigation is completed.The non-conformances with the returned components were not identified.However, the root cause or the most probable root cause is not confirmed.

• 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: 13509442
• MDR Text Key: 285434412
• Report Number: 2249723-2022-00268
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• 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 Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1