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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 Problem Fluid Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information: the device was received for evaluation. The anticoagulant line was connected to the check valve. The female connector of the anticoagulant line was found to be broken, which would lead to a leak. The female connector is made of polyethylene terephthalate glycol (petg). The reported condition was verified. The cause of the condition was 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. 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.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the anticoagulation line luer lock of a prismaflex m100 set was leaking a small amount of blood. This occurred during use when infusing flolan through the line. The customer clamped the line and stopped using it without any issue. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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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 Key7073375
MDR Text Key162884107
Report Number8010182-2017-00177
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 01/10/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number106697
Device Lot Number17D2705
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2017
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

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