MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-53
Medical Device Problem Codes	Inability to Auto-Fill (1044); Difficult or Delayed Positioning (1157); Failure to Calibrate (2440)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1, full event site address: (b)(6).Supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer during use that cs300 intra-aortic balloon pump (iabp) the pump is alarming "check iab catheter" and has been in standby for several minutes.The device had autofill failure and unable to calibration message.No harm or injury to the patient was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields.Corrected fields.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component code), h11.(b)(6) called from the icu department about a pump with a patient.The pump had alarm "check iab catheter" and had been in standby for several minutes.A chest film had been done and location was pending.They have tried the start key, and they have tried repositioning the patient.They also rebooted the pump without resolve.Advised them to press the iab fill key, but it would not engage.They were never able to get the fill key to activate.They once again rebooted the pump to perform a "fill" and this time advised them to manipulate the sheath hub while the pump was autofilling.Also had them dial the aug control down 3 bars to attempt the fill.After this autofill, the pump displayed the autofill failure alarm, and the unable to calibrate message.At this point time exceeded 20 minutes and they called the physician for possible removal.(b)(6) will save the catheter once removed for return to getinge for qc testing.A return iab kit will be sent to the icu department.Followed up with (b)(6) at 415pm.The iab was removed and saved, and a new balloon was placed in the patient successfully.No repair information available.In future if we receive any repair information will reopen and update the investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d1, d4 (version or model #, catalog #, udi #).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: 21705726
• Report Number: 2249723-2025-0001455
• Device Sequence Number: 10010576
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: (01)10607567108704
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/03/2025

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-UC-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 06/19/2025; 07/01/2025; 07/03/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 06/24/2025; 07/01/2025; 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 40 CC IAB
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 61 KG