• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 107142
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem Air Embolism (1697)
Event Date 07/01/2019
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during patient treatment with a prismaflex hf1400 set, the arterial luer lock connector had broke off, and was stuck inside the y-connector that was connected to normal saline. This resulted in air entering the patient. The patient presented with shortness of breath and was placed on a ventilator to relieve the symptoms. The patient has recovered with no lasting effects and is now being treated with ordinary dialysis. No additional information is available.
 
Manufacturer Narrative
Additional information: the actual device was received for evaluation. Visual inspection revealed that the cone of the male luer connector of the access line was broken inside the priming accessory (y-line). The y-connector, which is intended for use during priming only, was not removed from the hf1400 set when connecting the patient to the prismaflex system. Per the prismaflex hf1400 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. Leaving the y-connector connected during patient treatment is considered user error. The reported condition was verified. The cause of the condition was not determined. A nonconformance has been opened to address this issue. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRISMAFLEX HF1400
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 Key8868818
MDR Text Key153526628
Report Number8010182-2019-00165
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042938
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/07/2019,12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2021
Device Catalogue Number107142
Device Lot Number19A2902
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/05/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/07/2019
Distributor Facility Aware Date07/15/2019
Event Location Hospital
Date Report to Manufacturer08/07/2019
Date Manufacturer Received12/17/2020
Was Device Evaluated by Manufacturer? Yes
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: 08/07/2019 Patient Sequence Number: 1
Treatment
PRISMAFLEX CONTROL UNIT
-
-