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 Overheating of Device (1437)

Patient Problem Ventricular Fibrillation (2130)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit was used as a backup after extracardiac operation, the patients heart rate on (b)(6) 2023 was recorded as 70-80 bpm.On (b)(6) at 9:30 am a system overheating message occurred.Ventricular fibrillation temporarily occurred patients hemodynamics were stable.Replaced with other cardiosave no particular change in the patient with respect to the situation is stable.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the cardiosave intra-aortic balloon pump (iabp), but was unable to reproduce the reported issue.The parts compressor, temperature sensor, fan, motor control board, front end board were replaced as part of pm., to avoid any further issues as a preventive measure.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h10.The following investigation was performed by the failure analysis and testing department (fat).The fat received a front end board p/n 0670-00-0769, with a reported of ¿system overheating¿.Performed visual inspection of the front end board per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed the front end board into iabp cardiosave test fixture for testing in accordance with procedure and the cardiosave service manual in an attempt to recreate the reported problem.Found that all functions were normal.The tests (3 hours) did not trigger the reported problem.The fat was unable to replicate the failure experienced by the customer.Part is no longer going back to the supplier, as the supplier is unable to test this part due to being too old of a revision, and thus has rejected it.Retaining the front end board in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the fat was unable to replicate the failure.The fat received a motor control board, p/n 0670-00-0765, with a reported of ¿system overheat message¿.Performed visual inspection per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed into cardiosave test fixture for testing in accordance with the cardiosave service manual, in an attempt to recreate the reported problem.Found that all functions were normal.The tests (3 hours) did not trigger the reported problem.The fat was unable to replicate the failure experienced by the customer.Part is no longer going back to the supplier, as the supplier is unable to test this part due to being too old of a revision, and thus has rejected it.Retaining the motor control board in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the fat was unable to replicate the failure.The fat received a temperature sensor probe p/n 0206-00-0734, with a reported of ¿system overheating¿.Performed visual inspection per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed into cardiosave test fixture serial number.Performed and tested in accordance with the cardiosave service manual.Found that all functions were normal.The tests (3 hours) did not trigger the reported problem.The fat was unable to replicate the failure experienced by the customer.Retaining the temperature sensor probe in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the fat was unable to replicate the failure.The fat received a cable assembly, fan, p/n 0012-00-1564-0, with a reported of a ¿system overheat message¿.Performed visual inspection per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed into cardiosave test fixture for testing of the reported problem.Performed and tested (2 hours) in accordance with the cardiosave service manual.Found that all functions were normal.The tests (4hour) did not trigger the reported problem.The fat was unable to replicate the failure experienced by the customer.Retaining the cable assembly, fan in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the fat was unable to replicate the failure.The fat received a compressor p/n 0119-00-0236, with a reported of the ¿system overheating¿.Performed visual inspection per the cardiosave service manual and found no visual damage and the part looks to be in good condition.Installed into the cardiosave test fixture.Performed and tested in accordance with the cardiosave.Found that all functions were normal.After an extensive testing (5 hours) the test did not trigger the reported problem of the ¿system overheating¿.The fat was unable to replicate the failure experienced by the customer.Retaining the compressor in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the fat was unable to replicate the failure.

Event Description

N/a.

• 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: 16947817
• MDR Text Key: 315403948
• Report Number: 2249723-2023-02393
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 59 KG