MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

Device Problems Improper or Incorrect Procedure or Method (2017); No Flow (2991)

Patient Problem Blood Loss (2597)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex set and a prismaflex control unit, there was no blood flow observed in the extracorporeal circuit (ec). It was reported the blood pump was running; however, no alarm was generated. Treatment was terminated without returning the ec blood to the patient. The blood loss was reported to 300ml. No patient symptom was reported; however, the patient received a blood transfusion. No additional information is available.

Manufacturer Narrative

Additional information: upon follow up it was reported heparin was used as an anticoagulant (dose unknown). It was reported a blood clot was noted at the access pod. The actual device was not available; however, a video of the sample was provided for evaluation. The video shows the y-connector, which is intended only for priming of the m100 set, was connected between the catheter and the access and return blood lines. Per the prismaflex m100 instruction for use (ifu) the operator should "use the set by following the detailed on-line instructions provided by the prismaflex control unit". After completion of the priming procedure, the prismaflex graphical user interface clearly states: "disconnect access line from y-line, connect to red luer lock on catheter (or other blood access)", i. E. The y-connector is not to be connected between the access line and the catheter as applicable for this event. 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 M100 SET
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; meyzieu cedex rhone
• 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: 8461252
• MDR Text Key: 140206563
• Report Number: 8010182-2019-00085
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 106697
• Device Lot Number: 18C0703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/29/2019
• 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

Patient Treatment Data

Date Received: 03/28/2019 Patient Sequence Number: 1

Treatment

PRISMAFLEX CONTROL UNIT