MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (TPE); SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA

Catalog Number 955470

Device Problem Crack (1135)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.During visual inspection of the provided photographic samples, showed the cone of the return male luer lock (mll) is broken.The reported condition was verified.Due to the nature of the provided sample, no further testing could be performed; therefore, the cause of the condition could not be determined.Consequently, the most probable cause of the leak is likely due to a broken mll cone.These components have been provided to the manufacturing plant already assembled by our supplier.A nonconformance has been opened to address this issue.Within in the nonconformance an investigation was performed allowing to identify that this event is due to: the presence of liquid on the mll cone or in the female luer lock (fll) before connection (e.G., use of disinfectant or drop of priming solution, drop of dialysate solution) which lubricates the connection.An improper connection handling (using the body of mll fistula and/or fll components for tightening the connection instead of screwing the coupling nut).Mll design or a combination of these factors can lead to an overtightening of the luer connection which can lead to blocked connection and/or cracks which can cause subsequent leakages.Design change control of the mll ongoing.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 ¿the nipple of the blue end¿ of a prismaflex tpe2000 set ¿was broken, and it broke in the lumen of the femoral vein catheter¿ during continuous renal replacement therapy.Therapy was discontinued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX SETS (TPE)
• Type of Device: SEPARATOR FOR THERAPEUTIC PURPOSES, MEMBRANE AUTOMATED BLOOD CELL/PLASMA
• 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 60073 ; 2242702068
• MDR Report Key: 18355085
• MDR Text Key: 330877313
• Report Number: 8010182-2023-00507
• Device Sequence Number: 1
• Product Code: MDP
• 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
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955470
• Device Lot Number: 22J0094
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Age: 65 YR
• Patient Sex: Female