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

Model Number	0998-00-3023-83
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	03/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Type of investigation not yet determined : a supplemental report will be submitted when additional information is provided.
Event or Problem Description
It was reported that during use on a patient using a cs300 intra-aortic balloon pump (iabp), the patient was in cardiac arrest and the console generated an autofill failure alarm.The customer confirmed that the helium connections were secure, the safety disk was screwed in tightly, and the iab fill port luer lock connection was secure.The helium tank was not empty and was open, but the pump would not autofill.The physician decided to remove the iab and replace it with a new one.The second iab was inserted successfully, but the console generated an autofill failure alarm once again.All connections were again confirmed secure.The helium tank was not empty and was open, but the pump still would not autofill.The customer was instructed to attempt a manual fill with 40cc air using a 50cc syringe and 3-way stopcock.The customer performed the manual fill without any issues and no resistance was reported.However, after the successful manual fill, the pump again generated an autofill failure alarm.The physician decided to have the patient transported to a different facility with the second iab still inserted, not connected to a pump.At this time, the customer has not attributed the event to the device.The associated intra-aortic balloons have been reported under medwatch 2248146-2022-00290 and 2248146-2022-00299.
Additional Manufacturer Narrative
Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) went to the customer's site to perform an evaluation.The fse attached a demo intra-aortic balloon (iab) with the correct helium extension tubing to the iabp unit and attempted to run the iabp unit in "internal" mode but received an autofill failure alarm.Communication / interviews (4111/3233): the fse later spoke with the customer over the phone.The customer informed the fse that they have contacted a third party service provider and will be shipping the iabp unit to the service provider for evaluation.A supplemental report will be submitted when additional information is provided.
Additional Manufacturer Narrative
Updated fields: h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: d1, d4(model#, catalog# & udi#), g1(contact person).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 14135724
• Report Number: 2249723-2022-00884
• Device Sequence Number: 4001136
• Product Code: DSP
• UDI-Device Identifier: 10607567108285
• UDI-Public: 10607567108285
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2022

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: 0998-00-3023-83
• Device Catalogue Number: 0998-00-3023-83
• Device Lot Number: N/A
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 04/07/2022; 11/01/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/07/2022; 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2007
• 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 50CC CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown