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

Catalog Number 110655

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Swelling/ Edema (4577)

Event Date 01/03/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately 2 hours after starting treatment with an ak 96 machine, the patient experienced chest tightness and abdominal swelling.The patient¿s blood was returned and treatment was discontinued.It was reported that the patient¿s weight was increased by 2900ml.The machine was replaced and treatment was restarted with no further issues reported.There was no medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H11: the device was not received for evaluation; however, the device was evaluated on site by a non-baxter technician, that found the machine working as per specifications and was unable to duplicate the event.No information was provided suggesting any defect or malfunction of the used machine and malfunction of the alarm triggering system.No information was provided suggesting that the machine didn't work according to specifications preventing any potential risk of injury to the patient or the user.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition could not be verified.The cause of the condition could not be determined.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 22643 ; SW 22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19174242
• MDR Text Key: 340945453
• Report Number: 9616026-2024-00024
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/19/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110655
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/24/2024
• Supplement Dates Manufacturer Received: 06/03/2024
• Supplement Dates FDA Received: 06/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: NI.
• Patient Outcome(s): Other