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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955626
Device Problems Protective Measures Problem (3015); Air/Gas in Device (4062)
Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that, following fifteen(15) minutes of continuous renal replacement therapy (crrt) using a prismax machine and a prismaflex m150 set, the patient's blood pressure decreased from 100/50 to 40/20 mmhg. Medical intervention, including titrating up vasopressors, was provided. An ¿air in blood¿ alarm was then generated and large amount of air was reportedly seen at the top of the m150 filter along with foam. The treatment was terminated without returning the extracorporeal (ec) blood to the patient. A blood loss of 217 ml was reported. An unspecified bolus of fluid replacement was provided together with albumin and, following decrease of hemoglobin from 8. 8 to 7. 2 g/dl, a blood transfusion was prescribed. No additional information is available.
 
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Brand NamePRISMAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12259358
MDR Text Key264504773
Report Number1416980-2021-04695
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? No
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: 08/02/2021 Patient Sequence Number: 1
Treatment
AUTO EFFLUENT SET; NORMAL SALINE; PRISMAFLEX M150 SET; THERMAX; THERMAX POUCH
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