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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
Model Number OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 12/06/2017
Event Type  malfunction  
Manufacturer Narrative
The alleged event was not confirmed by the manufacturing plant. The device was not returned to the plant for investigation. All companion samples were sold and distributed. An investigation of the product history records was conducted by the manufacturer. There was one approved temporary deviation notice on the lot. It is unrelated to the reported complaint event. There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint. This includes non-conformances, rework, labeling, process controls and any other occurrence in production. The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.
 
Manufacturer Narrative
A supplemental report will be submitted upon completion of the plant¿s investigation.
 
Event Description
It was reported to technical support that a major blood leak occurred during a patient's hemodialysis treatment. Follow-up with the clinic nurse indicated that there was a minor blood leak observed in the dialyzer. The blood was not re-infused back in the patient. The patient was reconnected to new blood lines and dialyzer and treatment was resumed on a backup hemodialysis machine. There was no medical intervention and the patient did not experience any complications as a result of the alleged event. Requested the sample for plant investigation.
 
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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 Key7145698
MDR Text Key256099448
Report Number1713747-2017-00407
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100149
UDI-Public00840861100149
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberOPTIFLUX 160NRE DIALYZER FINISHED ASSY.
Device Catalogue Number0500316E
Device Lot Number17HU01018
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 Received12/29/2017
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

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