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); Unexpected Shutdown (4019)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

Accessible for testing: and communication/interviews: a getinge field service engineer (fse) spoke with the facility's biomed and was told not to visit the facility to check the pump.The biomed discovered the pump shutdown because the pump was not docked all the way while running on battery power.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the on-call perfusionist called originally inquiring of how long the balloon could be dormant in the body before it had to be removed from the patient.Getinge support informed the on-call perfusionist that 30 minutes was how long the balloon could remain dormant.Getinge support inquired as to what the issue was and he stated he was unsure as he was not at the hospital and was calling from his home.The on-call perfusionist called again about 20 minutes later stating the hospital had removed the catheter from the patient and asked getinge support to call nurse caring for the patient for details.Getinge support called the nurse and he stated the batteries on the pump did not seem to be charging in any of the electrical outlets they had utilized.The nurse also stated that the cardiosave intra-aortic balloon pump (iabp) had been providing therapy the entire 3 days prior.The nurse stated the patient was stable and therapy was likely to be discontinued the following morning if the event had not occurred.There was no harm or injury to patient and no adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, e1 (site country), g3, g6, h2, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10.A getinge field service engineer (fse) spoke with the facility's biomed and was told not to visit the facility to check the pump.The biomed discovered the pump shutdown because the pump was not docked all the way while running on battery power.

• 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: 13863892
• MDR Text Key: 290311311
• Report Number: 2249723-2022-00618
• 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: 01/29/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: IAB CATHETER
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 97 KG