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

Catalog Number 109841

Device Problem Inaccurate Information (4051)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that an error in translation regarding pediatric patients weight occurred when translating instructions for use from the english language to estonian or baltic counties on a prismaflex set hf20 occurred regarding the pediatric patients weight.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization eua201769 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.

Manufacturer Narrative

H10: the actual device was not available for investigation; however, a retained sample of instruction for use (ifu) was evaluated.The estonian ifu translated into english states: "prismaflex m60 should not be used in children weighing more than 11 kg.Prismaflex m100 and m150 kits should not be used in patients with body weight exceeding 30 kg.¿ the correct sentence in the english ifu states: "prismaflex m60 should be restricted to children with a body weight greater than 11 kg, and m100/150 sets should be restricted to patients with a body weight greater than 30kg.¿ the reported condition was verified.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SET 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: 14880504
• MDR Text Key: 299887265
• Report Number: 8010182-2022-00179
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: EN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 109841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: No
• 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