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 03/12/2019

Event Type  malfunction  

Event Description

It was reported that during cs300 intra-aortic balloon pump therapy, blood was observed in the balloon catheter.The iabp unit is to be checked to for blood back to the unit.There was no patient harm, serious injury or adverse event reported.Related iab complaint # (b)(4).

Manufacturer Narrative

Trackwise complaint number: (b)(4).Internal autonumber: (b)(4).This report is being submitted as the result of a retrospective review conducted in capa (b)(4).The customer has not requested getinge to evaluate the iabp.However, a company representative contacted the facility's biomed by email and was advised that the biomed evaluated the iabp and wanted an estimate for repairs.The customer has not reported back to getinge on the status of the unit.Evaluation conducted by hospital biomed department.

• 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: 16065266
• MDR Text Key: 307259305
• Report Number: 2249723-2022-03452
• 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
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER