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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 103452
Device Problems No Audible Alarm (1019); Improper or Incorrect Procedure or Method (2017)
Patient Problem Blood Loss (2597)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). The actual device was inspected on site by a biomedical technician. A calibration of the arterial pressure transducer including verification of the alarm window during a simulated treatment and the inspection of the machine's functionality was performed. All tests were completed successfully. The reported condition was not verified. It was determined that the phoenix machine functioned according to all manufacturers' specification. The most likely cause leading to the arterial patient line disconnection is related to a user error of using a third party accessory between the patient¿s vascular access and extracorporeal circuit in combination with the movement of the blankets that covered the patient's access. The phoenix operator's manual warns the user about reducing the risk of needles disconnection by ensuring that the venous needle and line are firmly secured to the access site area according to facility protocol; to ensure that the patient's access is visible at all times during the dialysis treatment; to inspect frequently the patient's access. The manual also instructs the user to only use accessories and disposables tested and validated with the phoenix machine. Warning "this manual contains a number of references to accessories and disposables for use with the phoenix machine. The phoenix machine has been tested and validated for use with the accessories and disposables listed in this manual. The manufacturer has not validated the use of accessories or disposables other than those specified in this manual. The manufacturer does not assume responsibility or liability for use of accessories or disposable other than those specified in this manual. It is the responsibility of the user to validate that other accessories or disposables provide safe and effective performance. " should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that at an unknown time during pediatric treatment using a cartridge and a phoenix control unit, the patient's arterial line which was connected to a third-party accessory connector became partially disconnected resulting in a blood loss observed "on the floor beneath the patient". The third-party connector had a leak and at some point (possibly when blankets were moved) became completely disconnected form the arterial bloodline. There were no alarms triggered by the phoenix control unit. No clinical symptoms were reported, however, a code blue was called and the patient was transferred to the pediatric intensive care unit where 2-3 units of blood and other unspecified fluids were administered. The patient was reported to be "fine" and was able to resume dialysis treatment the next day. 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 CORPORATION
deerfield IL
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 Key10616702
MDR Text Key216353412
Report Number9616240-2020-00002
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K070643
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103452
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/02/2020
Event Location Hospital
Date Manufacturer Received09/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2015
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: 10/01/2020 Patient Sequence Number: 1
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