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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
Catalog Number 0500318E
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Event Description
A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer. No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer. No blood test strips were used. The patient was able to successfully complete hd treatment with new supplies on the same machine. The sample was discarded.
 
Manufacturer Narrative
Corrected occupation: biomedical engineer. Plant investigation: a production records review was performed on the reported lot. An investigation of the device manufacturing records was conducted by the manufacturer. 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 reported complaint. The lot passed all release criteria.
 
Event Description
A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer. No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer. No blood test strips were used. The patient was able to successfully complete hd treatment with new supplies on the same machine. The sample was discarded.
 
Manufacturer Narrative
Corrective data: event date in follow up 2 is (b)(6) 2018.
 
Event Description
A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer. No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer. No blood test strips were used. The patient was able to successfully complete hd treatment with new supplies on the same machine. The sample was discarded.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a dialyzer was leaking at the beginning of the hemodialysis (hd) patient's treatment once blood touched the dialyzer. No defect/damage observed to the dialyzer or its packaging was noted, and an internal blood leak was visually observed at the head of the dialyzer. No blood test strips were used. The patient was able to successfully complete hd treatment with new supplies on the same machine. The sample was discarded.
 
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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 Key7098196
MDR Text Key252230627
Report Number1713747-2017-00390
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,user f
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/01/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue Number0500318E
Device Lot Number17NU01002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received04/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/03/2017
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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