MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F16NRE DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0500306E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A dialysis lab manager reported that an internal dialyzer blood leak occurred approximately thirty minutes into a patient's hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate lines and in the dialysate compartment of the device.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.A blood leak test strip was used to test for the presence of blood, and it tested positive.Medisystems bloodlines were used for the treatment.There was no reported damage identified on the dialyzer.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was approximately 200 ml.The lab manager 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 patient was able to complete treatment after being re-setup with new supplies on a different machine.The sample was reportedly sent back for evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port caps and adapter caps were returned attached to the dialyzer.Blood was noted throughout the dialyzer and coagulated blood was present within both headers.The returned sample was subjected to a laboratory bubble point test.A leak was not detected, possibly due to the coagulated blood.The dialyzer was then subjected to destructive disassembly for further visual examination.Upon extraction of the fiber bundle, a broken fiber was identified on the non-cavity id end at approximately 275 degrees, with the dialysate ports situated at 0 degrees.The broken fiber was flush with the polyurethane (pu) surface.The opposing end of the broken fiber was within proximity on the same end.Further examination of the fiber bundle did not identify any other broken fibers, damage, or irregularities.The inferior surface of both polyurethane potting ends were examined for voids; no voids were noted.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then 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.The investigation into the complaint was able to confirm the reported event.

• Brand Name: OPTIFLUX F16NRE DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 10025376
• Report Number: 1713747-2020-00177
• Device Sequence Number: 2812936
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 0500306E
• Device Catalogue Number: 0500306E
• Device Lot Number: 19DU01001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE