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

Model Number	0998-UC-3023-57
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	09/22/2024
Type of Reportable Event	Serious Injury
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, postoperative of no more than 36 hours of emergency mitraclip, with arrow catheter, right femoral, 40cc, inserted by the intensive care physician with control plate, patient with a diagnosis of cardiogenic shock, the cs300 intra-aortic balloon pump (iabp)had an auto-fill failure.They changed the helium cylinder, when mounting a new full cylinder, it did not auto-fill after several attempts and after 3 minutes the console passed the auto-fill and started counterpulsation.The patient presented hypotension due to the assistance pulse.Potential harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d9, g3, g6, h2, h3, h6 ( type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and the equipment was inspected, and the following errors were observed in the system log: error 3 (system failure), internal code 39 (refers to a counterpulsation failure due to a lack of helium gas), error 57 (autofill failure) and internal codes 13-0 and 6-0 (the autofill process failed due to a lack of vacuum in the backup disk).The first error appeared, indicating that the console stopped counterpulsating due to a lack of helium.According to information from the usvec service, the helium cylinder has been replaced with a charged one.Error 57 appeared on september 23 at 4:27 am and stopped appearing at 6:40 am.Based on the data obtained, a diagnosis was made of the counterpulsation console components through service tests.It was observed that the safety disc tests were failing.The safety disc was inspected and it was found that, intermittently, helium gas was not passing to the balloon.For this reason, the disc was replaced.It consists of the following components: safety disc and condensation system.Service tests and general functional tests were performed, and no malfunctions were found.The counterpulsation equipment was left operating with a patient simulator and test balloon to verify its operation for 24 hours.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, d9, g1, g3, g6, h2,h3, h4, h6( type of investigation, investigation findings, investigation conclusion), h11.Despite attempts to gain additional information from the customer, no further details were provided.There is no evidence within the record of an evaluation of the cs300 by a field service technician.As of now, the investigation is closed, if any new information is received future related to part replacement will reopen the complaint and update it.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,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: 20497423
• Report Number: 2249723-2024-0004312
• Device Sequence Number: 4105950
• Product Code: DSP
• UDI-Device Identifier: 10607567108742
• UDI-Public: (01)10607567108742(11)SI118241B8
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-UC-3023-57
• Device Catalogue Number: 0998-UC-3023-57
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 02/06/2025; 04/01/2025
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 02/07/2025; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2008
• 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 CATHETER, RIGHT FEMORAL, 40CC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 60 KG