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 Backflow (1064); Device Contamination with Body Fluid (2317)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/19/2022

Event Type  Death  

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) customer stated blood in the helium tubing; blood verified with several close-up photos of the tubing.Alarm history log printed and reviewed.There were no alarms prior to noticing the blood in the helium tubing.Reviewed the cardiosave ifu recommendation to stop therapy immediately and call the physician to remove the balloon within 30 minutes due to risk of thrombus.Complaint information collected for both the balloon and console.Related balloon complaint (b)(4).

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate the issue.The fse stated that there was no blood found in the pim / safety disk and that there were no signs of blood inclusion anywhere.The fse then performed functional and safety checks.The unit passed all functional and safety tests per factory specifications.The unit was then returned to the customer and cleared for clinical use.

Event Description

Related balloon complaint (b)(4).

• 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: 16099332
• MDR Text Key: 306678137
• Report Number: 2249723-2023-00088
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/19/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 08/18/2023
• Supplement Dates FDA Received: 08/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON SERIAL NUMBER: (B)(6).
• Patient Outcome(s): Death
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 94 KG