MAUDE Adverse Event Report: Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3013-55
Medical Device Problem Codes	Device Alarm System (1012); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an angiogram cs300 intra-aortic balloon pump (iabp) had difficulty in remove the balloon.There was dried out blood spots in the helium tubing.The doctor was notified and they attempted to remove the balloon in icu and in theatre without any success.The patient had to be airlifted to another hospital where there was a vascular surgeon on call and the balloon had to be removed surgically in theatre.At no point were there any alarms on the pump to notify the customer that there are blood detected or helium loss.After our technician inspected the pump no alarms appeared relating to the incident and the pump was filled with blood on the inside.
Additional Manufacturer Narrative
Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.The report contains both an adverse event and a product problem, but only the adverse event designation could be submitted due to a temporary system limitation.

• Brand Name: CS100 Intra-Aortic Balloon Pump, English, 220V
• 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: 50495823
• Report Number: 2249723-2026-0004040
• Device Sequence Number: 13377600
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: (01)10607567107295
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• 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: 08/06/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Sensation Plus 50cc Intra-Aortic Balloon (IAB).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 231 LB