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 Appropriate Term/Code Not Available (3191)

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

Event Date 10/05/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit (b)(4) had "issues with augmenation" and they could not see the iab inflating.The pump showed that there was an augmentation of 90 but the augmentation waveform was flat and the aug alarm was displayed.They switched the patient to another pump.(ch279407e8) this was successful until they began to transport the patient and the pump alarmed with "gas gain", then suddenly made a screeching sound, and "system failure" was displayed.The screen then went blank.They rebooted the pump and it happened again.They switched to a 3rd cardiosave which is currently working without alarms.The patient is stable and no harm was reported.

Manufacturer Narrative

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had augmentation malfunction.Customer experienced augmentation alarms over and over and wasn't sure the balloon was inflating.The customer replaced the iabp with another device and continued therapy.Getinge field service engineer (fse) arrived and found nothing in the logs that would indicate a problem with the device.Performed full functional and safety tests.All test pass.Biomed will let this device pump for a day with test balloon and trainer.Device pumped without interruption over night.Returning device to customer and clearing for clinical use.There was patient involvement but no 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: 15626028
• MDR Text Key: 304081767
• Report Number: 2249723-2022-02690
• 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
• Report Date: 04/01/2024

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 03/30/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 40CC
• Patient Age: 58 YR
• Patient Sex: Male