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

Catalog Number 114364

Device Problem Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Swelling/ Edema (4577)

Event Date 06/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that, during treatment with hemodialysis machine ak 96, air and water leakage occurred at the elbow on negative pressure pump.After 3 hours and 40 minutes of dialysis treatment, the patient felt swelling and discomfort of the upper limbs and face.The treatment was stopped.The accumulated ultrafiltration volume displayed by the ak 96 showed 2.19l.Post treatment weight recording was (b)(6) kg indicating that the patient had gained 3.7l compared to the pre treatment weight and their blood pressure had increased to 183/90 mmhg.No alarm was generated during the treatment.A new 4 hour treatment was initiated, using a different ak 96 dialysis machine and the patient reportedly had no discomfort.No additional information is available.

Manufacturer Narrative

Additional information added to h6 and h10.H10: the device was not received for evaluation; therefore, a device analysis could not be completed.A device history review revealed no issues that could have caused or contributed to the reported issue.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.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 12224734
• MDR Text Key: 263392970
• Report Number: 9616026-2021-00036
• 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
• Report Date: 08/26/2021

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: 114364
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 08/09/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR
• Patient Weight: 56