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

Catalog Number	109990
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an external blood leak was observed originating from the connection between the syringe and syringe line of a prismaflex m150 during continuous veno-venous hemodiafiltration.Approximately one hour into therapy; shortly after starting the heparin, the blood ¿backed up into the syringe line and started leaking from the connection between the syringe line and syringe¿.The blood loss was approximately 100-200ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS(M)
• 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: 17352200
• Report Number: 8010182-2023-00271
• Device Sequence Number: 5065883
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K080519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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: 12/31/2024
• Device Catalogue Number: 109990
• Device Lot Number: 23A0056CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/24/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAX
• Patient Sex: Unknown