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 Failure of Device to Self-Test (2937)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) failed all manifolds test.There was no patient involvement.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

A getinge field service engineer evaluated and confirmed device failed the pim and membrane portions of the all manifolds test while completing the installation checklist.Affixed red sticker to device indicating the unit is not cleared for clinical use at this time.Fse replaced pneumatic module assembly.Completed full pm, calibration, safety, and functionality checks were completed per the service manual.All checks passed factory specifications.Device is functioning in accordance with factory specifications at this time and is cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Installed the patient interface module into the cardiosave test fixture and tested the patient interface module to factory specifications per procedure and the cardiosave service manual.The failure analysis and testing dept.Verified the failure of the patient interface module failure - "failed membrane leak test at 6mmhg".Specification of testing shall be (membrane diff prs.±6 mmhg).Retaining the patient interface module in the fat dept.Further investigation may be required by sustaining engineering.If further investigation is not required, the pim shall be scrapped.The failure analysis and testing dept.Installed the safety disk into the cardiosave test fixture and tested the safety disk to factory specifications and the cardiosave service manual.The fat dept.Verified the failure of the safety disk failure of the membrane differential pressure with the results of 6 mmhg.Factory specification is +/- 6mmhg.Retaining the safety disk in the fat dept.Further investigation may be required by sustaining engineering.If further investigation is not required, the safety disk shall be scrapped.No longer going to sustaining for further analysis.Investigation is completed.Retaining the part in the failure analysis and testing department per.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• 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: 15889825
• MDR Text Key: 304780196
• Report Number: 2249723-2022-03072
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• 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: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.