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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEDOLLA MODENA MONITORS PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103453
Device Problems Fluid Leak (1250); Smoking (1585)
Patient Problem Respiratory Distress (2045)
Event Date 11/29/2017
Event Type  Injury  
Manufacturer Narrative
(b)(6). (b)(4). This report addresses the third 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.
 
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Brand NamePHOENIX
Type of DeviceDIALYZER, 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 Key7251562
MDR Text Key99351980
Report Number9616240-2018-00003
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number103453
Device Lot NumberN/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 FDA02/08/2018
Distributor Facility Aware Date01/12/2018
Event Location Hospital
Date Report to Manufacturer02/08/2018
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/21/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1
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