MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF20; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	109841
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Date of Event	08/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The associated lot numbers were 21a1203z and 21c1007z.Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to provide continuous renal replacement therapy (crrt) to treat low weight (8 kg to 20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (covid-19) pandemic.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported approximately 16 hours into a pediatric continuous renal replacement therapy (crrt) in hemodiafiltration (cvvhdf) mode (connected to extracorporeal membrane oxygenation circuit), with a prismaflex control unit and two (2) units of prismaflex hf20 clotted resulting in a blood loss.The amount of blood loss was not specified.Treatment was restarted two and a half hours later with a new prismaflex hf20.Nine hours into treatment, the filter clotted resulting in an unspecified amount of blood loss.Treatment was restarted again on a new prismaflex hf20.On the following day (the date of this event, reported as seventeen hours into treatment), the filter clotted resulting in an unspecified amount of blood loss.It was reported that the prismaflex control unit generated a malfunction: self-test failure code 2, code 4, and code 6 alarms.The patient required packed red blood cells transfusion for the event.The outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: h6 and h10.H10: 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 HF20
• 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 ; 2242702068
• MDR Report Key: 12508078
• Report Number: 8010182-2021-00277
• Device Sequence Number: 12487407
• Product Code: KDI
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

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 Catalogue Number: 109841
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 09/21/2021
• Supplement Report FDA Received Date: 11/15/2021
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX CONTROL UNIT; PRISMAFLEX CONTROL UNIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 10 KG