MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID, 3.1 EDITION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-65

Device Problems Device Alarm System (1012); Restricted Flow rate (1248)

Patient Problem Insufficient Information (4580)

Event Date 12/11/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during patient use, the cardiosave intra-aortic balloon pump (iabp) unit is frequently alarming "catheter inspection required" and" iab circuit leak.".

Manufacturer Narrative

Additional information: e3 is unknown("initially it is submitted has other healthcare professional").It was reported that the cardiosave intra-aortic balloon pump (iabp) had frequent alarms of ¿catheter inspection required¿ and ¿iab circuit leak during use.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Catheter inspection required (flow restriction), alarm for iab circuit leak.No reproducibility during inspection.The problem can be resolved by replacing the circuit.Reported as a suspected kink in the catheter.Did regulator adjustment.All manifold test pass.

• Brand Name: CARDIOSAVE HYBRID, 3.1 EDITION
• 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: 18368929
• MDR Text Key: 331096843
• Report Number: 2249723-2023-05390
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1