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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 Problem Imprecision (1307)
Patient Problems Chest Pain (1776); Dyspnea (1816); Blood Loss (2597)
Event Date 01/19/2019
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 a phoenix machine. Did not detect air bubbles during patient treatment. The patient presented with cough, thoracic pain and shortness of breath. The patient was in pain for five minutes and was treated by administering oxygen. It was reported that the patient was walking without assistance after treatment and no hospitalization was required. 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 Key8346612
MDR Text Key136494546
Report Number9616240-2019-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K103832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2019 Patient Sequence Number: 1
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