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 09/11/2020

Event Type  malfunction  

Event Description

It was reported that during use, the cardiosave intra-aortic balloon pump (iabp) had blood back into the unit.

Manufacturer Narrative

A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and traced blood from the pneumatic module assembly (pim) to the scroll compressor.The stm removed the contaminated parts and repairs are on hold until the repair purchase order is approved.Subsequently, the stm returned to the customer's site at a later date and performed the repairs on the iabp unit.The stm replaced the pneumatic module assembly (0997-00-1178), the pim to backplane cable assembly (0012-00-1640), tidal volume disk (0202-00-0142), helium reservoir assembly (0997-00-0565), pressure-vacuum reservoir (0202-00-0170-03), muffler to reservoir fitting (0103-00-0626), o-ring (0354-00-0175), related filters (0103-00-0499 & 0103-00-0709), in-line female pneumatic fitting (0103-00-0657-01), tubing (0008-00-0377), and related screw kits.The stm then performed preventative maintenance (pm) including 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).

• 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: 16065421
• MDR Text Key: 308501388
• Report Number: 2249723-2022-03467
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1