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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 955558
Device Problem No Visual Prompts/Feedback (4021)
Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Blood Loss (2597)
Event Date 12/12/2020
Event Type  Injury  
Manufacturer Narrative
The prismax device was evaluated on site by a qualified baxter technician. A calibration and system self-test (sst) were performed with no further issues reported. Scheduled preventive maintenance (pm) was also executed. The return pressure sensor was replaced. The reported problem was verified. The event history log review was performed and it confirmed the occurrence of a technical alarm b1116: ¿return pressure self - test fail¿, as intended after a failed pod reposition and requiring the return pressure sensor to be changed. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported condition was verified. The cause was a faulty pressure sensor. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a pediatric patient experienced arterial hypotension and hypoxia during a continuous renal replacement therapy treatment, using a prismax machine and a prismaflex hf20 set. It was reported that the prismax machine generated an alarm: b1116: ¿return pressure self - test fail¿ and the screen became black. This error code was preceded 15 minutes before by alarm t0525 (return disconnection). The treatment was ended with only part of the extracorporeal blood being returned to the patient using the hand crank. During the change of circuit, the pediatric patient was in arterial hypotension and hypoxic which required refilling by supply of platelets and plasma. At the time of this report, the patient has recovered from the event. 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 60073
2242702068
MDR Report Key11149326
MDR Text Key226111544
Report Number1416980-2020-08440
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
K190910
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 01/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/14/2020
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 Reuse

Patient Treatment Data
Date Received: 01/11/2021 Patient Sequence Number: 1
Treatment
PRISMAFLEX HF20 SET
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