MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 98; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	955607
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available a supplemental report will be submitted.
Event or Problem Description
It was reported that during hemodialysis therapy, the ak 98 machine triggered a 'heparin pump error' and the entire amount of heparin was administered to the patient.Treatment was completed without further issues.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6, h11.H11: the device was not received for evaluation; however, the device was evaluated on site by a qualified vantive technician.A review of the machine log files confirmed the occurrence of a heparin error.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the reported heparin pump malfunction was determined to related to operator error during the setting of delivery parameters before the start of therapy.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 98
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21093674
• Report Number: 9616240-2024-00029
• Device Sequence Number: 21010655
• Product Code: KDI
• UDI-Device Identifier: 07332414124519
• UDI-Public: 07332414124519
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K232467
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Catalogue Number: 955607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown