MAUDE Adverse Event Report: DATASCOPE CORP. SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET); SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0684-00-0576-01
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
The complaint was received through a direct call from the customer to the emergency support program.The reporter called for assistance with a gas loss alarm on a cardiosave during use and stated he was contacted by the unit after they received the gas loss alarm, swapped the console, and were still receiving the alarm on the 2nd pump.He was explained the nature of the alarm and based on the information the bedside team gave regarding the patient¿s hemodynamics and clinical picture, the alarm was likely caused by febrile temperatures and possible movement.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields: b4, d7a, g3, g6, h2, h6 (type of investigation, investigation findings, component codes and investigation conclusion), h11.Corrected field: h6 (medical device ¿ problem code).Product was not returned so an exact cause of the issue could not be identified.However, based on our investigation, a gas loss can occur due to one or more of the following probable causes.Gas loss in iab circuit.A gas loss in the iab circuit takes place when the pump detects a helium loss due to a leak or high rate of diffusion in the iab circuit.When a cumulative shuttle gas loss exceeds a nominal 5 cc hr dynamic limit a gas loss alarm is triggered.The alarm activates only when the iab inflation period 80 msec and deflation period 250 msec.Causes of gas loss in iab circuit.1.Patient condition such as febrile or tachycardic.Gas gain in iab circuit.A gas gain in the iab circuit takes place when a gas gain has been detected in the iab circuit.When a cumulative shuttle gas gain exceeds 5 cc relative to the last autofill volume.The alarm activates when iab inflation period 80 msec and deflation period 250 msec.
Event or Problem Description
N/a.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB & ACCESSORIES (W/PRESSURE TUBES, NO STYLET)
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer (Section G): DATASCOPE CORP.; 15 law drive; fairfield NJ 07004
• Manufacturer Contact: ewelina chorlowska ; 15 law drive; fairfield, NJ 07004
• MDR Report Key: 24930981
• Report Number: 2248146-2026-0000921
• Device Sequence Number: 12056922
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: (01)10607567108605(10)3000513355(17)281112(11)251112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0576-01
• Device Lot Number: 3000513355
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/12/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/12/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IABP
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 90 KG