MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AK 96 MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 114362

Device Problem Filtration Problem (2941)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported an excessive ultrafiltration event occurred on an ak 96 machine.After four hours of hemodialysis therapy, the expected ultrafiltration volume was 3100ml; however, the actual ultrafiltration volume was 3700ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Additional information added to h3, h6 and h10.H10: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician.The technician did not provide any information of their device evaluation; therefore, the reported condition could not be verified.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 96 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17613470
• MDR Text Key: 321871633
• Report Number: 9616026-2023-00060
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414111984
• UDI-Public: (01)07332414111984
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/28/2023

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: 114362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/04/2023
• Supplement Dates FDA Received: 09/28/2023
• 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
• Patient Age: 49 YR
• Patient Sex: Male