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 False Positive Result (1227); Device Displays Incorrect Message (2591)

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

Event Date 09/23/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a repeated low helium alarm.

Manufacturer Narrative

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

Manufacturer Narrative

Getinge field service engineer evaluated the unit, but was unable to reproduce the reported malfunction.The fse replaced the helium regulator as a preventive measure.The fse exercised the unit with no fail.The fse performed a full calibration and functional check per the factory calibration procedures.The iabp was returned to the customer and cleared for clinical use.The following investigation was performed the technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The helium regulator was observed per the cardiosave service manual with visual damage.The failure analysis and testing dept.Could not install the helium regulator into the cardiosave test fixture and verify the leak as per factory specifications per procedure and the cardiosave service manual.Helium transducer regulator could not be tested due to physical damage.Helium transducer regulator will be held in the fat dept.Per procedure.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a repeated low helium alarm.There was no patient harm reported.

• 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: 15544593
• MDR Text Key: 302831925
• Report Number: 2249723-2022-02545
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 06/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249723-01/24/2023-003-C
• Patient Sequence Number: 1