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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SEPXIRIS150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAFLEX SEPXIRIS150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955617
Device Problems Fluid Leak (1250); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/25/2021
Event Type  malfunction  
Manufacturer Narrative
Prismaflex sepxiris set 150 (jp) is similar to prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c. Prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c have been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during treatment with a prismaflex sepxiris set 150, an external blood leak from the return injection port located upstream of the deaeration chamber occurred. An anticoagulant (nafamostat mesilate/ futhan), was administered via the injection port using a 20g needle and a non baxter syringe pump. After twenty (20) hours of treatment, an obstruction alarm was generated by the syringe pump and the operator removed the 20g needle to replace it. However, blood was observed to leak out from the hole where the needle had been inserted. A new 20g needled was inserted in the same hole and the blood leak was stopped. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAFLEX SEPXIRIS150
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 Key12281775
MDR Text Key265202780
Report Number8010182-2021-00235
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955617
Device Lot Number20K0406
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
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: 08/05/2021 Patient Sequence Number: 1
Treatment
20G NEEDLE.; NIPRO EXTENSION TUBE.; SYRINGE PUMP FROM TERUMO.
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