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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/07/2022
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) using a prismax machine, a prismaflex st150 set and a thermax blood warmer unit, alarms for "thermax cover open" and "return extremely positive'" were generated.Treatment was stopped without extracorporeal blood (ec) returned to the patient.A blood loss of 217 ml was reported.The patient received a blood transfusion.After the patient was disconnected, blood was visible in the effluent bag.No additional information is available.
 
Manufacturer Narrative
Additional information added to b1, h1, h3, h6 and h10.The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.The device was lined and primed with no issues noted.A short 20-minute simulated therapy was successfully performed.No malfunction was detected.An event history log review was performed, and no clear device malfunction was identified as the prismax machine was triggering dedicated alarms to notify the user of the conditions with the machine or setup.The log file confirmed that no bld alarms are recorded, and the blood observed passing to auto effluent occurred after the patient was disconnected from the treatment.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Based on additional information received, the prismax machine was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
PRISMAX MACHINES
Type of Device
DIALYZER, 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
brooklyn park MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16102445
MDR Text Key306701105
Report Number3003504604-2022-00044
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/08/2022
Initial Date FDA Received01/05/2023
Supplement Dates Manufacturer Received01/27/2023
Supplement Dates FDA Received02/08/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
PRISMAFLEX ST150 SET; THERMAX BLOOD WARMER UNIT
Patient Outcome(s) Required Intervention;
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