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 Break (1069); Misconnection (1399)

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

Event Date 12/14/2023

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 a fiber optic port problem.There was no reported injury.

Manufacturer Narrative

Corrected data: a2, a3, a4, b5, d10, e3, h6 (problem code) updated data: b4, g3, g6, h2, h10, h11.

Event Description

Brantley called from the cardiac cath lab about a patient on a cardiosave pump.The iab was just inserted and they cannot get the iab into the fo port on the pump.Brantley says that something is broken inside the pump fo port that is obstructing the fo iab cable.It was suggested switching for another pump if available.They have a pump, but the helium is low.I suggested transducing the central lumen with the flush line, but there isn't one attached to the catheter.The steps to connect to the pump and zero were given.There was no reported harm or injury to the patient.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings, component codes and investigation conclusions), h10.Additional customer contact phone: (b)(6).A getinge field service engineer fse was dispatched to the site to evaluate the unit.Fse states that customer broke the blue fiber optic connector.I replaced it and performed a complete system checkout.Unit passed all testing except the fiber optic wave form was not present when put on my tester.It appears that the fiber optic module is bad.He will open a new complaint and repair order for that since it is covered by the contract.This repair is not covered since it is customer abuse of unit.Unit has been returned to customer and is cleared for clinical use with non fiber optic catheter.

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: 18383538
• MDR Text Key: 331213993
• Report Number: 2249723-2023-05442
• 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,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAQUET FO IAB
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 89 KG