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

Catalog Number 955603

Device Problem Protective Measures Problem (3015)

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with an ak 98 machine, the patient experienced a greater weight loss than expected.Weight loss was reported to be between (b)(6).There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the ak 98 machine is designed to implement compensation of the ultrafiltration (uf) measurement regularly during treatment to keep measurement errors within specification.Any deviation is supervised by the independent uf supervision system and the operator is notified if necessary.Two independent systems are considered state of the art.There is no data indicating that the ak 98 failed in triggering an alarm to notify the user if the limits were reached.This does not have the likelihood to cause or contribute to death or serious injury if this were to recur.There is no reasonable evidence to suggest that there was any malfunction or defect involving the ak 98 machine.The reported deviation was within specification.The device performed as intended.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the device was evaluated on site by a qualified technician.During the visual inspection, the qualified technician observed that the blackbox analysis showed that the ultrafiltration (uf) cell and ultrafiltration supervision (ufs) were not aligned as there was a difference of 200 to 300 ml/min between the two values.Further checking, the qualified technician found the uf cell was faulty.To resolve the issue, the qualified technician replaced the uf cell and a simulated test checked the residual value in the measuring glass and found it within the limit and the device was returned to clinical use.The reported condition was verified.The cause was uf out of calibration.Review of complaints and service history for the machine involved in this complaint determined that other four (4) similar events occurred on this machine.Based on the investigation of this complaint and on the review of the manufacturing records, it can be concluded that the cause leading to the last four (4) events of excessive weight loss was highly likely related to one of the electrovalves diva/byva/tava that internally leaked affecting the taration of the uf cell.This was also confirmed by the fact that, after the last complaint in which those electrovalves were replaced, no other similar event occurred on this machine.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AK 98
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11942309
• MDR Text Key: 264619042
• Report Number: 9616240-2021-00001
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K201809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1