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

Catalog Number 955470

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 10/02/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6).H10: the actual device was not available; however, photographs of the sample were provided for evaluation.During visual inspection of the provided photographic samples the male luer lock was observed to be 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.Therefore, 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 tubing of a prismaflex tpe2000 set disconnected at the blue port due to a crack during continuous renal replacement therapy.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: 18104289
• MDR Text Key: 327883049
• Report Number: 8010182-2023-00445
• Device Sequence Number: 1
• Product Code: MDP
• UDI-Device Identifier: 07332414123482
• UDI-Public: (01)07332414123482
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 22F0070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• 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 Number: 1
• Treatment: NI.