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

Catalog Number 955595

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

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).The actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the provided photos showed the cone of the return male luer lock (mll) is broken.The observed leak is likely due to a broken mll cone.The reported condition was verified.A potential cause of the condition could have been related to 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.

Event Description

It was reported that during use with one unit of a prismaflex m100 set, an external blood leak from return luer connector was observed.It was reported that unspecified damage at the connector was found.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX SETS (M)
• 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; 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: 14497067
• MDR Text Key: 296325617
• Report Number: 8010182-2022-00132
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124397
• UDI-Public: (01)07332414124397
• 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: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 955595
• Device Lot Number: 21C2002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• 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