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 Failure to Run on Battery (1466); Battery Problem (2885); Noise, Audible (3273)

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

Event Date 01/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported after completing patient transportation the cardiosave intra-aortic balloon pump (iabp) shut down and made a loud high-pitched noise.The patient was transported from maui memorial to straub medical center, and it was 3 plus hours total.They had brought with them a spare battery in a pelican case.After they transferred the patient onto a pump at straub, the rescue shut down and made a loud high-pitched noise.They attempted to insert their back-up battery; however, it was not charged.The noise continued, despite the pump being completely off.That was the primary reason for the call.As i spoke with customer, the noise suddenly stopped.Customer then gave me the rest of the details of the events that had transpired.Confirmed the patient was not on the device as it shut down.Customer stated they did confirm prior to leaving maui that the 2 batteries in the pump were fully charged.However, they had not confirmed that the extra battery in the case was charged.I did recommend they debrief with maui memorial icu after the pump was returned and sequester the pump for biomed or until the events get sorted out.There was no direct patient involvement or harm to patient.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse spoke with the customer and they stated that their 3rd battery was already discharged prior to use.They think that it was never charged after a prior transport a week or 2 ago and are working on updating their process to ensure all batteries are fully charged prior to transport.The fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.Returned to customer and cleared for clinical use.The fse spoke with biomed and they are going to do a battery run test to make sure the batteries are holding for 60 mins each but have not requested service at this time.

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: 18653756
• MDR Text Key: 334762623
• Report Number: 2249723-2024-00492
• Device Sequence Number: 1
• Product Code: DSP
• 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
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2024
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 83 KG