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

Catalog Number	109990
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during continuous renal replacement therapy (crrt) using a prismaflex m150 set, the nurse noticed a disconnection "near the air separation chamber" and "the plastic pump came loose in front of the rotary connection of the blue" return line.It was reported that the "treatments were stopped." it was further reported that the patient experienced "significant blood loss" and required a blood transfusion of 2 units of blood.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The actual device was not available; however, a photograph of the sample was provided for evaluation.The photo showed that there is an external blood leakage at the level of the connection between the deaeration chamber and the return line.It also showed that the connection was loose and tape was put at the level of the connection.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS
• 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: 19745070
• Report Number: 8010182-2024-00314
• Device Sequence Number: 15086063
• Product Code: KDI
• UDI-Device Identifier: 07332414090005
• UDI-Public: (01)07332414090005(10)24A0065(17)251231
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2025
• Device Catalogue Number: 109990
• Device Lot Number: 24A0065
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNSPECIFIED DIALYSIS MACHINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown