MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, TYPE B PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-53
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, a cticu rn reported a gas loss alarm on a cardiosave intra-aortic balloon pump (iabp) during use.The customer reported that perfusion had evaluated the system and that the patient and pump were otherwise functioning appropriately; however, the gas loss alarm caused the pump to enter standby for approximately 10-15 seconds.The customer verified that there was no blood in the helium tubing, all connections were secure and appropriate, and no visible kinks were present in the tubing.The nature of the gas loss alarm was reviewed, and based on the reported clinical condition, the alarm was discussed as potentially related to changes in intrathoracic pressure.Recommended troubleshooting steps were reviewed, and the customer was advised to contact clinical support if the alarm recurred several times within one hour.The customer was appreciative of the support.No patient harm or injury was reported.
Additional Manufacturer Narrative
The parent investigation evaluated cardiosave gas loss alarms involving the iab circuit due to patient condition(s).A gas loss alarm is activated when cumulative helium loss exceeds 5 cc relative to the last autofill volume.Alarm require an iab inflation period of at least 80 milliseconds and a deflation period of at least 250 milliseconds, may occur in all operating modes, and result in system venting and iab deflation.Gas loss may be associated with helium leakage, diffusion, or patient conditions such as fever or tachycardia.Based on the available information, no iab or iabp malfunction was identified through this parent investigation.This issue continues to be monitored within the manufacturer¿s quality system.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Common Device Name: System, Balloon, Intra-Aortic And Control
• Manufacturer (Section D): Datascope Corp.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): Datascope Corp.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 50942938
• Report Number: 2249723-2026-0004500
• Device Sequence Number: 9552349
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 239 LB