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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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Brand NamePRISMAFLEX M100 SET
Type of DeviceDIALYZER, 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 Key8461252
MDR Text Key140206563
Report Number8010182-2019-00085
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeVM
PMA/PMN Number
K041005
Number of Events Reported1
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 Received03/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/01/2020
Device Catalogue Number106697
Device Lot Number18C0703
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 Received04/29/2019
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
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