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

Model Number 0998-00-0800-55

Device Problem Gas/Air Leak (2946)

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

Event Date 01/31/2024

Event Type  malfunction  

Event Description

It was reported that during use on a patient, a gas leak occurred during the night of (b)(6) 2024 to (b)(6) 2024 on the cardiosave intra-aortic balloon pump (iabp).The problem is persistent.There was no patient harm or injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the fse did a functional check with patient simulator and intra-aortic balloon, after more than 15 minutes of operation, the cardiosave did not generate any alarm.Users told the fse that the intra-aortic balloon used is from the arrow teleflex brand (ultraflex iab / 7.5 fr / 2.5mm /40 cc).The service did not keep the arrow intra-aortic balloon therefore impossible to request an expertise.Functional check with patient simulator and the iapb consumable under the same conditions as the user settings.Functional control with the different simulators without having any alarm.Checking the ecg cable.Leakage test of the safety disk (pim), drive and fill manifold test of the compressor.Analysis of log errors.Verification of the correct functioning of the leak alarms by simulating them.New functional check for 30 minutes, there was no alarm.After the various analyzes and the various tests, the cpbia cardiosave console does not presents no problem.Equipment tested according to the manufacturer and operational protocol.

• Brand Name: CARDIOSAVE HYBRID W/ 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: 18687830
• MDR Text Key: 335248787
• Report Number: 2249723-2024-00571
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• 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
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW TELEFLEX BRAND ULTRAFLEX IAB