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

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.

• Brand Name: PRISMAFLEX SEPXIRIS150
• 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; 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 Key: 12281775
• MDR Text Key: 265202780
• Report Number: 8010182-2021-00235
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955617
• Device Lot Number: 20K0406
• 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 Received: 08/27/2021
• 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.