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 Battery Problem (2885)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had depleted and non charging batteries.There was no harm or injury to the patient and no adverse event was reported.

Manufacturer Narrative

Testing of actual/suspected device: a facetime call was made to assess the screen.An attempt was made to disengage the console and reengage but the attempt was not successful the battery icons on the screen and on the batteries did not show that they are charging.The pump was in the hybrid mode.Another pump was not available.The user stated that this happened on another pump on this patient 2 days ago so it was replaced with the current pump.At the time of the facetime call, the pump was working and there were no alarms.The patient was stable, and sitting in a chair at the bedside as the iab is in the axillary position.The user planned to call their biomed team to discuss the issue.The serial number and appropriate patient information was given.The user did not know if the first pump was sent to biomed, and the user did not have the serial number information.The location of that first pump was unknown.A separate complaint report was be filed for this pump.During a follow up at a later time, the user confirmed that they spoke to the biomed department and they were able to supply the user with full batteries.They informed the user that they have had issues like with this before and they will be reaching out to getinge service.A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

Updated fields: b4, e1 (site country), g3, g6, g7, h2, h4, h6, h10, h11 corrected field: a2 (age) the age is wrongly added in initial emdr.The patient age is not provided.Additional information was requested from the customer with regard to the repair and status of the iabp.The customer reported that the biomed is aware of the repair, they were able to supply the user with full batteries, and that all functional and safety checks to meet factory specifications were performed, and all passed.The iabp was then cleared for clinical service.

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: 13666721
• MDR Text Key: 286931361
• Report Number: 2249723-2022-00444
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2022
• Initial Date FDA Received: 03/04/2022
• Supplement Dates Manufacturer Received: 01/12/2024
• Supplement Dates FDA Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 83 KG