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

Catalog Number 114364

Device Problem Filtration Problem (2941)

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

Event Date 08/30/2022

Event Type  malfunction  

Event Description

It was reported that an excess fluid loss (amount not specified) occurred during treatment with an ak 96 machine.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Initial reporter first name: initial reporter last name: initial reporter facility name: initial reporter address: should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h6 and h10.H10: the device was evaluated on site by a qualified technician.To resolve the issue, the qualified technician calibrated the uf cell and the machine was running normally.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 ; 2242702068
• MDR Report Key: 15465350
• MDR Text Key: 302183757
• Report Number: 9616026-2022-00094
• Device Sequence Number: 1
• Product Code: KDI
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 114364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2022
• 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