MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problems Leak/Splash (1354); Gas/Air Leak (2946); Insufficient Information (3190)

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

Event Date 12/20/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs.

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.

Manufacturer Narrative

Corrected data: b5, h6 (problem code).Updated data: b4, e1(initial reporter), e2, e3, g2, g3, g6, h2, h10, h11.

Event Description

It was reported that before use, the cardiosave intra-aortic balloon pump (iabp) unit has inhouse repairs for helium leak.There was no patient involved.

Manufacturer Narrative

It was reported that the cardiosave intra-aortic balloon pump (iabp) helium leak.Getinge field service engineer (fse) the problem was confirmed directly in the laboratory.Work performed: disassembly of the crankcase, replacement of the complete fill manifold.Functional checks and diagnostic tests.Preventive replacement of the o-ring connection between the trolley and the console carried out.Regular functioning tests.Final result: repair completed.The device has passed all performance and safety tests according to the parent company's specifications.No patient involved.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 18435690
• MDR Text Key: 331792296
• Report Number: 2249723-2024-00025
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,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?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 02/06/2024; 02/23/2024; 03/26/2024
• Supplement Dates FDA Received: 02/07/2024; 02/27/2024; 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.; UNKNOWN.