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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF20 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF20 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 109841
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 08/08/2021
Event Type  malfunction  
Manufacturer Narrative
The associated lot numbers were 21a1203z and 21c1007z. Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to provide continuous renal replacement therapy (crrt) to treat low weight (8 kg to 20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (covid-19) pandemic. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that approximately nine and a half hours into a pediatric continuous renal replacement therapy (crrt) in hemodiafiltration (cvvhdf) mode (connected to extracorporeal membrane oxygenation circuit), with a prismaflex control unit and a prismaflex hf20, a hemolysis event occurred. The event was further described as the effluent was observed to have a red/brown color. It was reported that the oxygenator in the extracorporeal membrane oxygenation circuit was changed overnight. A failed self-test code 4 alarms was generated by the prismaflex control unit approximately two hours into treatment, however, no blood leak detected alarms occurred. The patient outcome was not reported. No additional information is available.
 
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Brand NamePRISMAFLEX HF20
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - MEYZIEU
7, av lionel terray, b.p. 126
meyzieu cedex rhone 69883
FR 69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12507441
MDR Text Key272505084
Report Number8010182-2021-00278
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number109841
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/21/2021 Patient Sequence Number: 1
Treatment
PRISMAFLEX CONTROL UNIT
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