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

Catalog Number 114364

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Diaphoresis (2452); Confusion/ Disorientation (2553)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that 1.5 hours after starting treatment with an ak 96 machine, the patient developed sweating, nausea, confusion and blood pressure was 81/60 mmhg.The ultrafiltration was stopped, however symptoms recurred 2 hours after dialysis and the patient was treated with fluid replacement and hemodialysis was stopped.During the patient dialysis, the interface buckle between the water outlet tubing of the substitution solution and the internal connection of the machine got loose, resulting in the possibility of a fluid leak.No alarm condition was reported in connection with the treatment.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, two (2) photographs were provided for evaluation.Based on the event description and on the provided picture, the leak occurred during use from the flow path and in particular, from the connection between the blue dialysis fluid tube to the machine.The cause was identified to be due to part failure.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
• 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: 12909394
• MDR Text Key: 281528567
• Report Number: 9616026-2021-00072
• 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,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 114364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/19/2022
• Supplement Dates FDA Received: 01/25/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female