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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX SETS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 106697
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. However, the reporter indicated that there was backflow/leak issue between the female connector on the anticoagulant line and the syringe. The female connector is made of polyethylene terephthalate glycol (petg). A potential cause of this condition was determined to be a compatibility issue between the device and flolan ph12, a glaxosmithkline (gsk) product. Gsk has issued hpra safety notice (b)(4) to the uk markets indicating that ¿flolan solution prepared with sterile diluent (ph12) must not be used with any preparation or administration materials containing polyethylene terephthalate (pet) or polyethylene terephthalate glycol (petg). ¿ per the safety notice, use of flolan ph12 with pet or petg components can lead to leaks due to cracking or damage. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
Date of event and therapy date was sometime in (b)(6) 2017. Should additional relevant information become available,a supplemental report will be submitted.
 
Event Description
It was reported that with a prismaflex m100 set blood was being drawn back into anticoagulation syringe. The set was being used with epoprostenol. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAFLEX SETS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE - MEYZIEU
meyzieu
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 Key7154084
MDR Text Key162885476
Report Number8010182-2017-00186
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K041005
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/06/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number106697
Device Lot Number17G2802
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 Received01/24/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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