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 Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Event Description

It was reported that during checkout, the cardiosave intra-aortic balloon pump (iabp) unit was leaking.It is unknown if there was any patient involvement.

Manufacturer Narrative

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

Event Description

It was reported while performing the b.17 field action checkout by a getinge service tech, the cardiosave intra-aortic balloon pump (iabp) unit was leaking.There was no patient involvement.

Manufacturer Narrative

Corrected information: section b5, b6, b7, d5, d11, e4, g3, h6.Additional information: section b4, e1, e2, e3, g4, g7, h2, h10, h11.

Manufacturer Narrative

A getinge field service engineer (fse) found the cardiosave intra-aortic balloon pump (iabp) to be leaking.Furthermore, the fse noted the unit had leaks in the pneumatics.So, in order to solve the issue, the fse replaced the drive manifold assembly and the helium reservoir.The fse also replaced the 9v daughter board battery which was supplied by the customer.The unit then passed all calibration, functional and safety tests performed.The unit was then returned to the customer and cleared for clinical use.The maquet national repair center technician received the drive manifold and performed visual inspection per the cardiosave service manual and found no visual damage.The technician then tested it in an attempt to recreate the reported problem.All functions were normal.The nrc was unable to replicate the failure.The drive manifold will be retained and scrapped per procedure.The maquet national repair center technician received the fill manifold and performed visual inspection per the cardiosave service manual and found no visual damage.The technician then tested it in an attempt to recreate the reported problem.All functions were normal.The tests did not trigger the reported problem of the unit had leakage from the fill manifold.The nrc was unable to replicate the failure.The fill drive manifold will be retained and scrapped 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: 15236529
• MDR Text Key: 305176879
• Report Number: 2249723-2022-02091
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• 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: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1