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 Failure to Sense (1559); Incomplete or Inadequate Connection (4037)

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

Event Date 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) units fiber optic pushes out of holder when you try to put fiber in.There was no patient involvement.

Manufacturer Narrative

Getinge field service engineer (fse) that encountered the issue replaced the fiber-optic sensor extension cable assembly.The iabp was tested and working properly.The iabp was returned to the customer and cleared for clinical service.The following investigation was performed by the technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The failure analysis and testing dept.Received part cbl, assy fo sensor with a reported unit failure of fiber optic pushes out of holder when you put fiber optic in.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Connected a know good fiber optic cable into the suspect defective connector and observed that the fiber optic cable did not securely lock into the fiber optic cable connector assembly.The failure analysis and testing dept.Was able to replicate the failure that the customer experienced.The cable assembly failed testing.Retaining the fiber optic cable assembly in the failure analysis and testing department per procedure.

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: 16755269
• MDR Text Key: 313489894
• Report Number: 2249723-2023-01960
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1