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 Codes	Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During an emergency support program call, a ccu rn contacted clinical support regarding connection of an arrow iab catheter to a cardiosave intra-aortic balloon pump (iabp) after the patient was transferred from an outside hospital using a teleflex pump.The customer reported that the helium connection was not compatible and requested guidance on transferring therapy to the cardiosave without returning the patient to the catheterization laboratory.The required driveline tubing adapter and appropriate size selection were reviewed, along with the connection process.After the iab was transferred from the teleflex pump to the cardiosave, a catheter restriction alarm occurred.Before additional troubleshooting could be performed, the customer reported observing thick, dark orange fluid coming from the iab catheter extender input.The customer was advised to reconnect the iab to the original pump, obtain a new cardiosave for exchange, and label the affected pump for biomedical engineering evaluation.Fse was dispatched to evaluated the unit, confirmed blood back event.Blood intrusion spotted in all pneumatic components.Pneumatic interface module, pneumatic lineset, reservoir, fittings, fill manifold, compressor and executive processor boards needs to be replaced.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50943038
• Report Number: 2249723-2026-0004501
• Device Sequence Number: 13136474
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: Arrow(IAB), Driveline Tubing Adapter,Teleflex Pump
• Patient Sex: Unknown