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

Catalog Number	107140
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photo showed a leak at the level of the anticoagulant line.Also observed was a drug syringe used during treatment that contained epoprostenol.Epoprostenol is not compatible with the polyethylene terephthalate glycol components of the prismaflex set.Per the set instructions for use, the drug should not be injected into the anticoagulation line as component damage can occur which may result in a leak.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the event was determined to be related to user error.A previous nonconformance was opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external blood leak was observed from the filter of a prismaflex hf1000 set during hemodialysis therapy.The volume of blood loss was not known.There was no report of medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX SET
• Common Device Name: 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 60073 ; 2242702068
• MDR Report Key: 20545154
• Report Number: 8010182-2024-00447
• Device Sequence Number: 18025527
• Product Code: KDI
• UDI-Device Identifier: 07332414069254
• UDI-Public: 07332414069254
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K042938
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 107140
• Device Lot Number: 24B0033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown