MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

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

Patient Problem Insufficient Information (4580)

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported by the customer that the cs300 intra-aortic balloon pump (iabp) unit developed some blood back.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp) unit and was able to reproduce the reported issue.The fse determined that the tubing needed to be replaced.To fix the issue, the fse replaced the tubing, blood detect, iabp, assy crm english, assy, safety disk,english and performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.(b)(6) hospital.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

It was reported that the cs300 intra-aortic balloon pump (iabp) had a balloon burst with potential fluid inside the unit.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: b5, h6 (medical device - problem code, component codes, investigation findings, investigation conclusions).A getinge field service engineer (fse) evaluated the unit.Bloodback was detected.The fse replaced the blood detect tubing, safety disk, and crm.The fse performed a full calibration, functional testing, and safety checks to factory specifications.The iabp was returned to the customer and cleared for clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 16065398
• MDR Text Key: 308479876
• Report Number: 2249723-2022-03463
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1