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

Catalog Number 110374

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the wheels on an ak 96 dialysis machine were loose which presented the risk of tipping over.This issue was observed during setup prior to patient use.There was no patient involvement.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 inspected the machine and confirmed that the foot unit threading was broken.The reported condition was verified.The cause of the reported condition was most likely related to incorrect handling of the machine by the user.It is highlighted in the ak 96 operator's manual, a caution for the hospital staff to, "avoid colliding with any objects when moving the machine as this could damage the equipment".To resolve the issue, the qualified technician quoted user for foot unit replacement.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 96
• 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: 16272157
• MDR Text Key: 308488970
• Report Number: 9616026-2023-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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: 110374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 03/22/2023
• 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