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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 0500316E
Device Problems Fluid Leak (1250); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A user facility biomedical technician reported an optiflux 160nre dialyzer that occluded at the beginning of a patient treatment. It was confirmed that the patient¿s blood was returned, but there was an estimated blood loss of 5ml. The patient completed treatment on the same machine with new supplies, with no injury, adverse event, or medical intervention reported. The dialyzer was discarded and is not available for return to the manufacturer.
 
Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation. According to the biomedical technician the dialyzer was discarded; however, a photograph was provided. The photograph shows a dialyzer housing and fiber bundle. A pinkish stripe is noted in the otherwise white fibers of the dialyzer. There is no physical damage to the fibers/dialyzer visible in the photograph. A production records review was performed on the reported lot. An investigation of the device history records (dhr) was conducted by the manufacturer. There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event. The lot met all release criteria. A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device. Therefore, the complaint is not confirmed.
 
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Brand NameOPTIFLUX 160NRE 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
MDR Report Key8169780
MDR Text Key130521834
Report Number1713747-2018-00492
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K002761
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Catalogue Number0500316E
Device Lot Number18KU06032
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/17/2018 Patient Sequence Number: 1
Treatment
FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
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