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

Catalog Number 107640

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported that during treatment with two units of prismaflex st150 set, a disconnection was observed between the y and the red line, further reported as "dialysis screwed off itself at the level of the red screw pitch".Treatment was ended without the extracorporeal blood being returned to the patient.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual devices were not returned for evaluation however three companion samples were provided.The visual inspection showed no defect on the sets (no damage or disconnected component).All connectors were correctly screwed and no issue was observed on these companion samples.Based on the information provided by the customer, the customer didn't remove the y priming accessory at the end of the priming, and left it connected between the patient catheter and the luer lock of the access line.This is a misuse of the product.Based on the additional information provided by the customer, the customer didn't remove the y priming accessory at the end of the priming, and leave it connected between the patient catheter and the luer lock of the access line (misuse of the product).The access line of the set must be directly connected to the patient catheter (i.E.Without any device between the access line and the catheter) via the male luer connector of the access line.The use of additional devices, such as three-way valves, stopcocks, y priming accessory during treatment or extension lines, may impair pressure monitoring.Per the instruction in the prismaflex graphical user interphase (gui), the y-line/connector used for priming of the prismaflex set must be removed prior to connecting the patient; the access and return lines are to be connected directly to the catheter.Thus, the use of the y-connector during treatment is considered use error.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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: 15579855
• MDR Text Key: 301835036
• Report Number: 8010182-2022-00300
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414075651
• UDI-Public: (01)07332414075651
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 107640
• Device Lot Number: 21G0301CA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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