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 Problems Device Contamination with Body Fluid (2317); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge stm was dispatched to evaluate the iabp.The stm found blood in pneumatic module.The stm replaced the pneumatic module assembly.The iabp passed all functional and safety tests performed and was then released to the customer and cleared for clinical service.Patient height 160cm.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 cardiosave intra-aortic balloon pump (iabp) shut down after the balloon burst.It was later clarified that the iabp unit did not shut down, but went into stand by.The customer clamped off the line when blood was observed.There was no report of patient harm, serious injury or adverse event.Balloon complaint: (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: 16067696
• MDR Text Key: 308260093
• Report Number: 2249723-2022-03428
• 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: Other Health Care Professional
• 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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MAQUET 7.5 FR 40 CC
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 110 KG