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

Catalog Number 110655

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter name and address: (b)(6).It was reported after installation in (b)(6) 2013, there is no record of replacing the ¿quick connector¿.On (b)(6) 2019, the last o-ring was replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during treatment with an ak 96 machine, an external fluid leak was identified at the dialysis fluid quick connector (hansen connector).It was reported an alarm was not generated.It was reported the fluid leak was due to a crack in the hansen connector.The patient experienced low blood pressure (77/51 mmhg) and weight loss of approximately 2200 gm.Treatment was ended and the extracorporeal blood was returned to the patient.The patient received 500 ml of saline and an unspecified amount of 5% glucose for the event.It was reported the patient recovered from the event.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation; therefore, a device analysis could not be completed.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 event was more likely associated with wear and tear of the hansen connector as a result of prolonged use.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B4/f8: date of this report in follow-up mdr #1 is being corrected from blank to 07/16/2021.

• Brand Name: AK 96
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12024799
• MDR Text Key: 265389528
• Report Number: 9616026-2021-00026
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR