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

Catalog Number 109841

Device Problem Obstruction of Flow (2423)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/11/2021

Event Type  Injury  

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 (b)(6)) 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 Description

It was reported that approximately four days into continuous renal replacement therapy (crrt) in hemodiafiltration (cvvhdf) mode (connected to extracorporeal membrane oxygenation circuit), with a prismaflex control unit and a prismaflex hf20, on a pediatric patient, the set clotted, resulting in blood loss 15 hours into treatment.The amount of blood loss was not specified.Treatment was restarted the following day (twenty-nine hours into this treatment), the filter clotted resulting in an unspecified amount of blood loss.Treatment was discontinued.The patient required packed red blood cells transfusion for the event.The outcome was not reported.No additional information is available.

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
• 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; 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: 12507470
• MDR Text Key: 272521607
• Report Number: 8010182-2021-00279
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 109841
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX CONTROL UNIT; PRISMAFLEX CONTROL UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 10 KG