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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500320E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/30/2017
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the device was returned to the manufacturer for physical evaluation. A visual examination of the returned device noted that the fiber bundle was wet with evidence of blood contamination. The fibers were streaked with blood residue and blood was noted within the dialysate compartment. Coagulated blood was observed in both heads of the cavity and non-cavity id ends of the dialyzer. Gross visual examination of the returned device identified a delamination on the non-cavity id end which extended from approximately 330º to 30º with the dialysate ports at 0º. The delamination manifested as separation of the polyurethane (potting material) from the dialyzer housing wall. The delamination in the polyurethane potting extended under the silicone o-ring. There were no other defects or irregularities visually identified on the fiber bundle or any of the molded dialyzer components. There are no other complaints reported on this lot. A production records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. The lot had two approved temporary deviation notices (dn) that were unrelated to the reported complaint. 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. The lot passed all release criteria. The investigation into the cause of the reported problem was able to confirm the failure mode. There was a confirmed delamination on the non-cavity id end of the dialyzer. The complaint has been deemed confirmed.
 
Event Description
A user facility nurse reported that a blood leak occurred immediately after initiation of the patient's hemodialysis (hd) treatment. The machine alarmed for blood leak and blood was visible internal to the dialyzer head and also within the effluent. Therefore, blood test strips were not used to confirm the presence of blood. No dialyzer defect or damage was visible. The patient¿s estimated blood loss (ebl) was noted as being approximately 280-290 ml 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 available to be returned to the manufacturer for evaluation.
 
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Brand NameOPTIFLUX 200NRE 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 Key7052096
MDR Text Key93440724
Report Number1713747-2017-00371
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100163
UDI-Public00840861100163
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
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2020
Device Catalogue Number0500320E
Device Lot Number17KU04007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2017
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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