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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2019

Event Type  malfunction  

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm observed blood on the blood return/drain line up to the filter before the purge assembly.The safety disk and condensation removal module (crm) were also contaminated with blood and the fill line had tiny specks of blood.The stm replaced the blood detect tubing, safety disk assembly, condensation removal module (crm) assembly and clear polyurethane tubing.The stm noted that nothing unusual was identified in the iabp log files then 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.Patient or person height (cm) 165.This report is being submitted as the result of a retrospective review conducted in capa (b)(4).

Event Description

It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) experienced a sudden severe intra-aortic balloon leak allowing blood to fill the helium tubing all the way to the safety disk.The iabp unit was turned off immediately.There was no known harm or injury to the patient and no adverse event was reported.

• 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: 16075554
• MDR Text Key: 308474386
• Report Number: 2249723-2022-03429
• 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
• Report Date: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• 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: 12/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC BALLOON
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 125 KG