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 Communication or Transmission Problem (2896)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) had an internal communication failure.User surfaced a system failure critical alarm.User swapped out console to continue treatment without issues.Unit turned over to biomed for resolution.There was no patient harm reported.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 ( type of investigation, investigation findings, investigation conclusion, component code), h10.It was reported during use that the cardiosave intra-aortic balloon pump (iabp) had internal communication failure.There was patient involved but no harm reported.Users surfaced a system failure critical alarm while on patient.Users swapped out console to continue treatment without issues.A getinge field service engineer evaluated and said that he unable to replicate user complaint.Successfully turned unit on, and completed a simulated treatment with testing catheter and trainer without issues.Fse identified code 58/124 logged in the system, subtext prolonged shuttle pressure, system failure.All transducers within specifications.Drive transducer offset reading at 25 mmhg, within specifications.Fse replaced suspect pressure transducer, 30 psia, 4" cable, drive manifold assembly.Post replacing aforementioned parts, calibrated system and successfully completed a full system checkout without issues.Unit calibrated and passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.The failure analysis and testing department received a drive manifold, pressure transducer 30 psia 4¿ cable with a reported of ¿code 58¿.Performed visual inspection of drive manifold, pressure transducer 30 psia 4¿ cable per the cardiosave service manual and found no visual damage and the part looks to be in a good condition.Installed into cardiosave test fixture.Performed and tested in accordance with the cardiosave service manual found that all functions were normal.The tests (30 minutes, 40 minutes) did not trigger the reported problem of the ¿code 58¿.The failure analysis and testing department was unable to replicate the failure experienced by the customer.Retaining the drive manifold and pressure transducer 30 psia 4¿ cable in the failure analysis and testing department per procedure.The root cause selection for this investigation will be ¿not confirmed¿ due to the failure analysis and testing department was unable to replicate the failure.

• 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: 17379826
• MDR Text Key: 319850355
• Report Number: 2249723-2023-03321
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/29/2024

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?: No
• 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?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1