MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID INT TYPE E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 09/06/2020

Event Type  malfunction  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp and noted that blood was observed in the safety disk and nafion tubing.The fse ordered the necessary parts and returned at a later date and installed a new safety disk and pneumatic module assembly (pim).Subsequently, the fse 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

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event where the intra-aortic balloon (iab) had leaked and blood had gotten into the iabp unit.There was no harm or injury to the patient and no adverse event was reported.Related complaint (b)(4).

• Brand Name: CARDIOSAVE HYBRID INT TYPE E/F 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: 16065422
• MDR Text Key: 308146013
• Report Number: 2249723-2022-03468
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1