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

Catalog Number 109841

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

Patient Problems Cardiac Arrest (1762); Respiratory Arrest (4461)

Event Date 12/16/2023

Event Type  Injury  

Manufacturer Narrative

Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization eua (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 Description

It was reported that the patient was started on continuous renal replacement therapy (crrt) with a prismaflex set due to acute stage 3 fluid overload.It was further reported that 20 minutes after starting therapy the patient became unstable and subsequently coded.The patient was placed on extracorporeal membrane oxygenation machine.The reporter confirmed that there was no malfunction with the prismaflex set and no alarms or clotting were noted.Crrt was restarted with another prismaflex set and no issues observed.No additional information is available.

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 (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 60073 ; 2242702068
• MDR Report Key: 18486932
• MDR Text Key: 332576828
• Report Number: 8010182-2023-00551
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414089443
• UDI-Public: (01)07332414089443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 109841
• Device Lot Number: 23B0085Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/07/2024
• 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: CONTROL UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 14 DA
• Patient Sex: Female
• Patient Weight: 3 KG