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 Material Rupture (1546); Device Contamination with Body Fluid (2317)

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

Event Date 06/27/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit balloon catheter ruptured.Service was requested for possible blood back.There was no patient harm or injury reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(medical device ¿ problem code,type of investigation, investigation findings, investigation conclusions), h10.It was reported that during use the cardiosave intra-aortic balloon pump (iabp) unit ¿balloon catheter ruptured¿.Service requested for possible blood back.A getinge field service engineer (fse) inspected entire iabp system for any blood contamination.Pim and pneumatic drive assembly were removed and examined.No blood infiltration found anywhere, no critical fault codes recorded.All manifold leak tests passed.Complete pm and changed screw kit (d040-00-0458-01), performed with full calibration, functional testing and electrical safety checks to factory specifications.Unit returned to customer and cleared for customer use.Patient involvement was there, no harm reported.

• 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: 17344607
• MDR Text Key: 319253564
• Report Number: 2249723-2023-03237
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1