MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE M PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-35
Medical Device Problem Codes	Failure to Sense (1559); Output Problem (3005); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge authorized representative evaluated the iabp.The unit failed the second portion of the fill manifold test that forms part of the all manifold test.To fix the issue, the engineer replaced the helium fill manifold assembly, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then cleared for clinical service, and currently in the warehouse as a stock item.
Event or Problem Description
It was reported that during pre-delivery inspection, the cardiosave intra-aortic balloon pump (iabp) failed the 2nd portion of the fill manifold test.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
The suspected defective helium fill manifold assembly was returned and received at the getinge national repair center (nrc) for part failure evaluation.A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h6, h10.The helium fill manifold assembly was returned for failure analysis.The failure analysis and testing dept.Received helium reservoir assembly with a reported unit failure of the fill manifold leak test failing.The failure analysis and testing dept.Performed a visual inspection of helium reservoir assembly and found the part to be in good condition.The failure analysis and testing dept.Installed the helium reservoir assembly into the cardiosave test fixture and tested the helium reservoir assembly to factory specifications per procedure and the cardiosave service manual.After performing the all manifold test, the failure analysis and testing dept, was able to replicate the failure of the fill manifold leak test failing.The fill valve differential test failed with a result of 24 mmhg.Factory specification is +-12mmhg.The helium reservoir assembly failed testing.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID TYPE M PLUG
• Common Device Name: 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: 11674732
• Report Number: 2249723-2021-00786
• Device Sequence Number: 2999592
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: 10607567109107
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2023

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
• Operator of Device: Other
• Device Model Number: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 03/30/2022; 04/07/2023
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/27/2022; 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown