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); Failure of Device to Self-Test (2937)

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

Event Date 11/29/2022

Event Type  malfunction  

Event Description

It was reported that out of box failure during installation, the cardiosave intra-aortic balloon pump (iabp) unit failed all manifold tests.There was no patient involvement.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, d9(device available for eval), g3, g6, h2, h3, h4, h6(investigation type, investigation findings, component codes & investigation conclusions), h10, h11 corrected fields: h6(problem code).*due to new information received, the aware date reported in the initial report should read: 29nov2022.The getinge field service engineer (fse) that encountered the issue escalated the issue and placed the order for the parts.Upon arrival of the parts, the fse replaced the patient interface module assembly(pim).Then, the fse attempted to complete the all manifolds test and discovered that the device failed the drive manifold test.The fse then commenced troubleshooting and detected leak within the drive manifold which was masked by previous pim failure.So, the fse placed the order for the additional parts.Upon arrival of the parts, the fse went on site and replaced the drive manifold assembly.Full pm, safety, calibration, and functionality checks passed factory specifications.The unit was functioning in accordance with factory specifications and was cleared for clinical use.The removed patient interface module assembly was returned to the failure analysis and testing department for investigation.Performed visual inspection of the patient interface module assembly per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed the patient interface module assembly into failure analysis and testing department iabp cardiosave test fixture for testing of the reported problem.Performed and tested the patient interface module assembly in accordance with procedure and the cardiosave service manual.Performed all manifold test/leak test in an attempt to recreate the reported problem.Found that all functions were normal.The all-manifold test/leak test did not trigger the reported problem of the unit fail the manifold test.The failure analysis and testing department was unable to replicate the failure experienced by the customer.Retaining the patient interface module assembly in the failure analysis and testing department per procedure.The removed drive manifold was returned to the failure analysis and testing department for investigation.Performed visual inspection of drive manifold per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed the drive manifold into the failure analysis and testing department iabp cardiosave for testing of the reported problem.Performed and tested the drive manifold in accordance with procedure and the cardiosave service manual, in an attempt to recreate the reported problem.The tests did trigger the reported problem of the unit failed all manifold test, looks like the drive manifold had a large leakage.The failure analysis and testing department was able to replicate the failure.Retaining the drive manifold in the failure analysis and testing department per procedure.

• 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: 16004057
• MDR Text Key: 307693271
• Report Number: 2249723-2022-03199
• Device Sequence Number: 1
• Product Code: DSP
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1