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

Catalog Number 955606

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

Event date: it was reported the patient missed therapy from (b)(6) 2022 to (b)(6) 2022.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient was unable to perform treatment at home with an ak 98 dialysis machine for three consecutive days.The patient presented to the pd clinic with breathing issues, blood pressure had shot up and iron levels have dropped considerably.According to the reporter, the patient recovered from the events after the visit to the renal clinic.No additional information is available.

Manufacturer Narrative

Additional information has been added to h6 and h10 h10: the device was not received for evaluation; therefore, a device analysis could not be completed.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 98 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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15692693
• MDR Text Key: 302674612
• Report Number: 9616240-2022-00017
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124502
• UDI-Public: (01)07332414124502
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• 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): Hospitalization
• Patient Sex: Male