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 Problem Device Contamination with Body Fluid (2317)

Patient Problem Insufficient Information (4580)

Event Date 09/11/2020

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cs300 intra- aortic balloon pump (iabp) was not working.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and observed blood in the drain tubing.The stm replaced the safety disk (0997-00-0985-01), condensation removal module (crm) (0997-00-0986-01), purge valve assembly (0104-00-0026), and the blood detect tubing (0008-00-0312).The stm noted that no other signs of blood were found throughout the iabp unit.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

N/a.

Manufacturer Narrative

The first name of the initial reporter in block e1 was been abbreviated due to field character limit; the full name should read alan freeman.

• 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: 16065423
• MDR Text Key: 308398839
• Report Number: 2249723-2022-03465
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

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: 01/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2009
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1