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

Catalog Number 955596

Device Problems Break (1069); Fluid Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Manufacturer Narrative

The actual device was not available; however, photographs of the sample were provided for evaluation. Visual inspection of the provided pictures showed the cone of the return male luer lock (mll) was broken. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. A nonconformance has been established to further investigate the connection components. 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. Prismaflex st150 set c 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.

Event Description

It was reported that during priming with a prismaflex st set, an external fluid leak was observed due to a damaged return connector. There was no patient involvement. No additional information is available.

• Brand Name: PRISMAFLEX SETS 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; 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: 13839951
• MDR Text Key: 287546359
• Report Number: 8010182-2022-00069
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955596
• Device Lot Number: 21F2303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial