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 Gas/Air Leak (2946); Temperature Problem (3022); Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 11/07/2023

Event Type  malfunction  

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit alarmed gas loss multiple times and alarmed heating, prompting to be restarted.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) had evaluated the unit and checked for the gas loss and temperature error.By checking through the logs there was gas loss alarms present in the logs and fault code 58 input temperature out of range which was being found.Then the fse had disassembled the patient interface module and it was being found that there was some blood intrusion into the module then the fse installed a pneumatic module assy, rohs and ran the unit through a complete calibration procedure , checked all fans and all are functional which is the inlet and outlet openings are clear of obstructions.The unit was reassembled and the unit ran on test balloon with no problems and unable to duplicate the temperature error at this time.The unit has been returned to the customer for the clinical use.

Event Description

It was reported that, the cardiosave intra-aortic balloon pump (iabp) unit alarmed gas loss multiple times and alarmed heating, prompting to be restarted.It is unknown the circumstance of the event and patient involvement.

• 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: 18133292
• MDR Text Key: 328073590
• Report Number: 2249723-2023-04860
• 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
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1