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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 Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported that a patient did not connect the blood line to the dialyzer properly therefore creating a blood leak. The patient¿s estimated blood loss is unknown. Additional information regarding patient outcome/status and demographics have been requested; however, to date none has been received.
 
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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
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 Key7592655
MDR Text Key110849433
Report Number1713747-2018-00196
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K082414
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup,Followup
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0500316E
Device Lot Number17EU01015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/12/2018 Patient Sequence Number: 1
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