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

Model Number	0998-00-3023-68
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
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 on wednesday 11/29/2023, an adverse event occurred with the cs300 intra- aortic balloon pump(iabp) the patient was having a cardiac arrest and they were trying to install the equipment in it.During the process the balloon did not work properly, displaying "system failure" message causing an audible warning.In the help menu a message was displayed that stated "incorrect operation of the microprocessor" and providing the action to restart the equipment and hold for 10 seconds.It was done and the error persisted.An attempt to synchronize the auto , pressure and ecg functions and none of these options , the equipment was able to start the treatment.There was no patient harm or injury reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and a technical assessment of the equipment was performed and verified that the equipment is experiencing an error during the autofill process, before starting the actuation cycle.It is also showing errors 45 and 65.As consulted in the service manual, checked; error 45 system failure - this fault is logged whenever a system failure is detected.Troubleshoot system based on additional faults logged.Error 65 pressure solenoid failure (k8) response; system failure, operation disabled - critical fault.K8 failure to open during initial autofill.Replaced drive manifold and leak tests were performed on solenoid valves k6, k6a, k7 and k8, in order to find errors related to the catheter self-filling system.Pneumatic performance tests, self-filling tests and engine calibration (compressor) were carried out.However, the equipment only presented an error during the safety disk leak test.The k8 valve activation tests were carried out to verify the pressure difference on the x2 transducer, verified that drive manifold valve k8 is not activating correctly, and does not activate the safety disc membrane.It will be necessary to request the drive manifold block to continue tests and analyze the performance of the equipment.The errors presented only occurred during the reported event.There were no other errors reported in the previous dates.Preventive maintenance of the equipment was carried out and all pneumatic tests and electrical safety tests of the equipment were performed with the electrical safety analyzer.The vacuum/pressure motor and the set of k3 and k5 solenoids, which were damaged, have been replaced.Additionally, a new motor and a test solenoid were installed, and the equipment no longer shows any operational abnormalities.The equipment underwent testing from 11:00 am until 5:30 pm on 02/15/2024 and from 09:00 am until 4:00 pm on 02/16/2024 without any failures.The calibration of the equipment is satisfactory.The atmospheric pressure was at 671 mmhg.The equipment is cleared for use.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18317454
• Report Number: 2249723-2023-05289
• Device Sequence Number: 6152632
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353(21)SI283003G8
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2024

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: 0998-00-3023-68
• Device Catalogue Number: 0998-00-3023-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 07/24/2024; 09/22/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 07/24/2024; 09/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2018
• 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: UNKNOWN IAB
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown