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

Model Number	0998-00-3023-65
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on patient, balloon ruptured.And blood entered the cs300 intra-aortic balloon pump (iabp).No harm reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse removed and replaced the affected parts contaminated by blood: purge valve assembly, fill manifold assembly, transducer block assembly, condensate removal module, tubing, 1/16¿ id polyurethane, male luer fitting, and blood detect tubing assembly.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23669718
• Report Number: 2249723-2025-0004863
• Device Sequence Number: 9846628
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)10607567108322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/30/2026

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: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/28/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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: TRANSRAY PLUS 40CC.
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 60 KG