MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-64
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) has a punctured balloon and a return of blood into the machine.
Additional Manufacturer Narrative
Updated field: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, investigation conclusions),h10, h11.Corrected field: d4(version or model, catalog, unique identifier (udi)), h6 (health effect ¿ clinical code, health effect ¿ impact codes).It was reported that cs300 intra-aortic balloon pump (iabp) with blood was found inside and autofill failure.Getinge field service engineer (fse) found auto fill fail noted 3 times, as well as ¿blood detect¿.When the console was opened, blood was found inside.Provide a quote including the replacement of parts contaminated by blood.Fse replaced the module k3 - k5 - crm, safety disk, blood detection cell - tubing calibration of the purge and volume of functional test (optical fiber, valves, blood detection cell, screen, keyboard, printer) pneumatic performance test battery test mains connection / satisfactory residual autonomy operational tests with simulator (pressure signal, ecg signal) standard electrical safety test.There was a patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4,g3,g6,h2,h10,h11 corrected data: d10.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19271020
• Report Number: 2249723-2024-01907
• Device Sequence Number: 6981251
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: (01)10607567108292(21)SA05339D6
• Combination Product (Y/N): N
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/03/2025

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: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• 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: 04/26/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 07/09/2024; 02/03/2025
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/21/2024; 07/09/2024; 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2009
• 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 BALLOON
• Patient Sex: Unknown