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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SET (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SET (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107640
Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone number and address: (b)(6).Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The device was not received for evaluation; therefore, a device analysis could not be completed, however, based on the information provided, the set was used for 283.15 hours.This is a misuse.Based on the instruction for use of the prismaflex st150 set; to assure adequate filter performance, it is recommended that the set be changed every 24 hours of use.However, the set must be changed after 3 days (72 hours).Continued use beyond this limit could result in rupture of the pump segments, with risk of patient injury or death.".The set was therefore used four (4) times longer than it should have been.This overuse is the cause of the bonding failure and observed leaks.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during treatment with a prismaflex st150, the effluent line was observed to have clotted and was leaking from multiple locations including where the line is glued into the circuit and around the effluent pump.The effluent pump tubing segment was ruptured.Air bubbles were also observed to be coming from the back of the filter.Several unspecified alarms were generated.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
PRISMAFLEX SET (ST)
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 - MEYZIEU
av lionel terray, b.p. 126
7
meyzieu cedex rhone 69883
FR   69883
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key16018331
MDR Text Key308528675
Report Number8010182-2022-00411
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
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 Other Health Care Professional
Type of Report Initial
Report Date 12/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2024
Device Catalogue Number107640
Device Lot Number22C0033
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2022
Initial Date FDA Received12/20/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PRISMAX MACHINE
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