MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID W/ E/F PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-55
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use the cardiosave intra-aortic balloon pump (iabp) experienced a blood back event.Patient was involved and no harm was reported.The device did not shutdown due to blood back.Fse was dispatched to evaluate the unit.It was established that blood had entered the device as a result of the user employing a non-original ¿balton¿ brand catheter and connecting it incorrectly; consequently, the pneumatic interface module, cartridge filter and assembly, and safety disk components failed due to blood ingress.The faulty components must be replaced with new ones.
Additional Manufacturer Narrative
Event site name: manisa sehir hastanesi dss upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 50942214
• Report Number: 2249723-2026-0004463
• Device Sequence Number: 9498694
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• 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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Balton-brand catheter
• Patient Sex: Unknown