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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
Additional information and device evaluation: the device was returned to the manufacturer for physical evaluation. A visual examination of the returned device noted that the fiber bundle was wet and revealed blood residue between the polyurethane cut surface and the screw flange on both ends of the dialyzer. A single potted fiber fragment was observed at approximately 350° on the non-cavity id end with the dialysate ports at 0°. No other damage or irregularity was noted on the returned sample. The dialyzer was subjected to a laboratory bubble point test and an internal leak was detected from a single fiber which emanated a steady flow of bubbles on the non-cavity id end potting cut surface where the single fiber was observed earlier during the visual examination. The dialyzer was then subjected to destructive disassembly. Upon extraction of the fiber bundle, the single fiber was located and viewed under magnification (20x) on the microscope. The fiber was observed to be indented and damaged at multiple locations. Further examination of the fiber bundle did not identify any other damage or irregularities. An investigation of the device manufacturing records was conducted by the manufacturer. There were two approved temporary deviation notices noted on the lot which were unrelated to the reported complaint event. There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event. The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint. The investigation into the cause of the reported problem was able to confirm the failure mode. There was a confirmed internal leak on the non-cavity id end of the dialyzer. The complaint has been deemed confirmed.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A user facility patient care technician (pct) reported that an internal blood leak occurred shortly after initiation of the patient's hemodialysis (hd) treatment. The machine alarmed for blood leak and there was a split visibly seen near the top inside of the dialyzer. Blood test strips were used and positively confirmed the presence of blood. The patient¿s estimated blood loss (ebl) was noted as being approximately 100ml as the patient¿s blood was not returned. No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient completed treatment with a new set-up of supplies on a different machine. The complaint device was stated to be available to be returned to the manufacturer for evaluation.
 
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Brand NameOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
475 west 13th street
ogden UT 84404
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key7151657
MDR Text Key256327140
Report Number1713747-2017-00412
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Model NumberOPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Device Catalogue Number0500318E
Device Lot Number17NU03007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/26/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/19/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/10/2017
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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