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 Problem Device Contamination with Body Fluid (2317)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2020

Event Type  malfunction  

Event Description

It was reported that the end user described lots of blood leaking into the helium tubing and into the cardiossave intra-aortic balloon pump (iabp).The end user notes "blood dripping from the bottom of the pump" they have disconnected the iab from the pump and awaiting a physician to remove the iab from the patient.Balloon complaint (b)(4).

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to evaluate the iabp.Upon initial inspection of the iabp, the stm found unit to be severely compromised with very few components not having been contacted by blood.Provided a service quote to the customer for repairs and discussed further options.Customer will inform when a decision to move forward has been made.Three (3) good faith efforts (gfes) to obtain the relevant repair and iabp status related to this complaint issue were made to the customer.However, despite our best efforts, customer has not responded to any of our gfes.Consequently, this complaint is being closed due to insufficient information.This report is being submitted as the result of a retrospective review conducted in capa (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: 16073383
• MDR Text Key: 308257100
• Report Number: 2249723-2022-03494
• Device Sequence Number: 1
• Product Code: DSP
• 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
• Report Date: 11/18/2022

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50CC
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 91 KG