MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during maintenance blood was found in the intra aotic balloon pump (iabp).
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11, d10.
Event or Problem Description
N/a.
Event or Problem Description
It was reported by getinge field safety engineer during maintenance the cs300 intra aortic balloon pump (iabp) customer discovered that there was blood in the system and leak in the iabp catheter.There was no patient involvement and no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1 (contact person ¿ mfg site), g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, investigation conclusion, health effect ¿ impact codes, investigation conclusion, component code) and h11.Corrected fields: b5, b6, b7, d5, d10, e1(initial reporter and event site email), e2, e3, h6 (medical device ¿ problem code).Fse replaced the affected parts assy crm german, tubing blood detect iabp and purge valve assembly iabp.Function and calibration ok.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: 22295045
• Report Number: 2249723-2025-0002671
• Device Sequence Number: 21051611
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/23/2025

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: Other
• Device Model Number: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/15/2025; 07/23/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/22/2025; 07/23/2025
• 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: GETINGE CATHETER.; N/A.; UNKNOWN.
• Patient Sex: Unknown