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

Catalog Number 107640

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fungal Infection (2419)

Event Date 06/14/2022

Event Type  Death  

Event Description

It was reported that a patient experienced ¿ineffectiveness of treatment following the establishment of an extra-renal purification following the appearance of an acute kidney injury" and bronchopulmonary aspergillosis despite ambisome treatment.The patient subsequently progressed to acute respiratory distress syndrome (ards).The patient was performing continuous veno-venous hemodiafiltration (cvvhdf) using a prismaflex st150.Ten days after the start of cwhdf treatment, the patient passed away.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information were provided.

Manufacturer Narrative

Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua200704 to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The device was discarded and the lot number is unknown; therefore, a device analysis could not be completed, however, based on the information receive the cause of the reported condition is user related.The function of dialysis is to filter blood.As per prismaflex st150 set instruction for use (ifu): ¿since drugs can pass through the membrane of the filter, the dosage of associated drug treatments must be adjusted for patients on continuous renal replacement therapy¿.This is a known effect of the device that would have been mitigated by appropriate dosage adjustment of ambisome by the clinician.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (ST)
• 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: 15639122
• MDR Text Key: 302079257
• Report Number: 8010182-2022-00317
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 107640
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NI.
• Patient Outcome(s): Required Intervention; Death
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 84 KG