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

Catalog Number 955606

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during treatment with an ak 98 machine, a high ultrafiltration (uf) occurred.The expected uf was 450ml; however, it was observed that the machine removed 525ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6, and h10: h10: the device was evaluated on-site by a qualified technician.The qualified technician observed that the machine removed 525 ml instead of removing 450 ml.It was 25 ml more than the acceptable criteria of +-50ml; therefore, it was determined that the ultrafiltration (uf) measuring unit was faulty.To resolve the issue, the qualified technician replaced the uf measuring unit.A simulated treatment was performed after replacing the uf measuring unit, and it was noted that the uf was within acceptable range.The reported condition was verified.The cause of the reported condition could not be determined.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 98 MACHINES
• Type of Device: 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: 18420839
• MDR Text Key: 331634470
• Report Number: 9616240-2023-00014
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 955606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1