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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 0500316E
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/06/2022
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility nurse reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment. It was reported blood was visually observed within the lines and the blood leak occurred immediately after initiation of the patient's hemodialysis treatment. The machine, a fresenius 2008k, alarmed appropriately with a blood leak alert. Fresenius combi set bloodlines were being utilized for the treatment. Blood test strips were not used. No damage was identified on the dialyzer prior to use. Immediately following the event, the patient was re-setup with new supplies on the same machine where they were able to complete treatment. The estimated blood loss was 200cc. It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event. The dialyzer was not available to be returned for a manufacturer evaluation as it was reportedly discarded.
 
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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
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer (Section G)
OGDEN MANUFACTURING PLANT
director, site quality
475 west 13th street
ogden UT 84404
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14370735
MDR Text Key291483238
Report Number0001713747-2022-00158
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162488
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number0500316E
Device Catalogue Number0500316E
Device Lot Number22CU06005
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2022
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: 05/12/2022 Patient Sequence Number: 1
Treatment
FRESENIUS 2008K MACHINE; FRESENIUS BLOODLINES
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