MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Smoking (1585)

Patient Problem Respiratory Distress (2045)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Initial reporter's address: - (b)(6).The user facility submitted medwatch (b)(4) for this event.This report addresses the sixth of seven (7) staff members involved in the event.The phoenix dialysis machine involved in the event was inspected and tested on-site by a baxter field technical service representative.At the time of the visit, the local biomedical engineer had already inspected the device.The local biomedical engineer found fluid leakage in the machine internal hydraulic circuit, originating from a hydraulic rigid connector.The electro-valve ev1 and the hydraulic electronic board were found to be damaged by heat.The local biomedical engineer repaired the machine by replacing the damaged parts.A review of manufacturing quality records was performed without identifying any potential relation between the observed issue and the manufacturing process.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the event.The cause of the generation of smoke was determined to be fluid leakage from the rigid hydraulic connector in the machine internal hydraulic circuit, which led to a short circuit and subsequent overheating of the ev1 electro-valve and hydraulic electronic board.Based on the results of the baxter technician¿s inspection and testing of the machine, no additional repairs were required and the machine was put back into service for clinical use.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient was undergoing a routine dialysis session using a phoenix dialysis machine, when smoke was observed to be coming from the machine.The patient was disconnected from the machine.The blood in the circuit was returned to the patient, and the patient was moved to another room where they were connected to a different dialysis machine to complete the dialysis session.The patient was not impacted by the event.A staff member was exposed to the smoke and experienced respiratory distress due to smoke inhalation.Bronchodilation treatment in the form of albuterol was provided to the staff member.The reporter stated that the staff member did not experience effects of the event beyond the day it occurred.No additional information is available.

• Brand Name: PHOENIX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; medolla modena
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7251632
• MDR Text Key: 99357503
• Report Number: 9616240-2018-00006
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 103453
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2018
• Distributor Facility Aware Date: 01/12/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2018
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2011
• 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
• Patient Outcome(s): Required Intervention