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

Catalog Number 103453

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during treatment with a phoenix machine, a patient experienced a high ultrafiltration.The amount of excess fluid was 1.2l, however, the ultrafiltration (uf) volume was set to 3.5l ( 2.3l in excess of the target weight of 89.6 kg.Reason for the setting was not specified).After 1h 40 min of treatment, the patient presented with a drop in blood pressure from128/74 mmhg to 86/70mmhg.The displayed accumulated uf volume at this time was 1.2l.The patient was treated with 500ml of saline and the ultrafiltration was paused.The uf volume was subsequently reduced to 1.5l and the treatment was continued.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated on site by a qualified technician.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.This event is associated with the set high ultrafiltration (uf) volume by the operator which was 2.3l in excess of the target weight and which led to an excessive weight removal from the patient with subsequent severe hypotension.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12275303
• MDR Text Key: 264994855
• Report Number: 9616240-2021-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: K070643
• 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: 10/04/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 103453
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 09/06/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR