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

Catalog Number 114364

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/07/2023

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during dialysis treatment with an ak 96 machine, an unknown type of blood line and a long-term catheter, ¿the patient¿s indwelling catheter falls off during treatment¿ resulting in excessive blood loss and death.The estimated amount of blood loss was unknown.It was further reported the machine generated an alarm for low venous pressure.The hospital reported that the cause of the indwelling catheter falling off was unknown.According to the reporter it was ¿suspected¿ that long-term indwelling catheter in the patient¿s neck was unscrewed.The cause of death was not reported.It was not reported of an autopsy was performed.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.It was reported that the machine activated pressure alarms, but no detailed information has been provided.No information was provided suggesting any defect or malfunction of the used machine.It was further reported "the machine has been used normally for the past few days, and the hospital also did not contact the agency engineer to inspect the machine on site." the machine triggered a low venous pressure alarm compatible with a catheter dislodgement that eventually caused the blood loss.The reported condition was not verified.The likely cause is due to the use error (failure to properly secure the patient access and potential failure to respond to the low venous pressure alarm).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 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 SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16886819
• MDR Text Key: 314743461
• Report Number: 9616026-2023-00032
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414112004
• UDI-Public: (01)07332414112004
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/07/2023

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/07/2023
• 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
• Treatment: NI.
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male