• 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 M100 SET 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 M100 SET DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The visual inspection of set revealed no anomalies. An air leak test under water was performed. This test showed a leak at the level of the connection between the effluent line pre-pump and the support plate. A closer inspection of the set was performed and a cut has been identified on the effluent line pre-pump in the notch of the support plate. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a prismaflex m100 set was leaking from the effluent line during priming. The client stopped the priming immediately and used another set for treatment. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7883384
MDR Text Key120537360
Report Number8010182-2018-00114
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/01/2019
Device Catalogue Number106697
Device Lot Number17I1303
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-