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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 Protective Measures Problem (3015)
Patient Problems High Blood Pressure/ Hypertension (1908); Chills (2191)
Event Date 05/27/2019
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after treatment with a phoenix dialysis monitor, the patient experienced chills, high systolic blood pressure, a drop-in hemoglobin, a rise in white blood cells (wbc) and a high ldh. It was reported at treatment start, the jugular ¿vascath¿ catheter had to be ¿twisted to make it stand up¿ to be able to work. The intended blood flow rate was 350 ml/min; however, it was reported the rate could not be increased above 250 ml/min. It was reported if the patient coughed or turned their head there was a pressure problem (unspecified). The arterial and venous pressures were reported to be in the range of 70-100 mmhg. It was reported an unknown alarm was generated towards the end of treatment which was overridden ¿several times¿. Treatment was discontinued and while the extracorporeal blood was returning the patient experienced symptoms of chills and high systolic blood pressure. It was reported after treatment ended, following completion of rinse-back, the extracorporeal circuit appeared as if blood had not been returned. A hemastick test was performed and was positive for blood. Labs were performed, and the results showed a drop in hemoglobin from 8. 9 to 6. 6 g/dl, a rise in wbc from 19000 to 53000 and high ldh (no numerical value provided). No medical intervention was provided for the events of chills or high systolic pressure. At the time of this report, the patient outcome was not reported. 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 Key8727486
MDR Text Key148970471
Report Number9616240-2019-00005
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,Followup
Report Date 06/24/2019,07/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number103453
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2019
Distributor Facility Aware Date05/29/2019
Event Location Hospital
Date Report to Manufacturer06/24/2019
Date Manufacturer Received07/18/2019
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: 06/24/2019 Patient Sequence Number: 1
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