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

Catalog 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	11/22/2019
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 user facility registered nurse (rn) reported that an internal dialyzer blood leak occurred approximately twenty minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed on the dialysate side of the dialyzer.There was no damage identified on the dialyzer.The machine, a gambro phoenix, alarmed with a blood leak.Blood leak test strips were used and they tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 250 ml.The rn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the event.The patient completed their treatment after being re-setup with new supplies on a different machine.The complaint device was reportedly available to be sent back to the manufacturer for a physical evaluation.
Additional Manufacturer Narrative
Additional information: d10, h3 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.The fibers were wet with indication of blood exposure; blood was noted throughout the dialyzer.In addition, coagulated blood was present within the header cap on the cavity id end of the dialyzer.The returned sample was subjected to a laboratory bubble point test.Internal leaks were detected in the form of a steady stream of bubbles emanating from the cavity id end potting cut surface located from approximately 5 degrees to 170 degrees, with the dialysate ports situated at 0 degrees.The dialyzer was subjected to destructive disassembly for further visual examination.Multiple potted fiber fragments and broken fibers were identified throughout the cavity id end of the dialyzer.The opposing ends of all fibers could not be isolated due to the quantity of broken fibers.Further examination of the fiber bundle did not identify any damage or irregularities, aside from the damaged fibers.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 were multiple approved temporary deviation notices reported on the lot which were unrelated to the complaint event.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: 9434049
• Report Number: 1713747-2019-00371
• Device Sequence Number: 2403070
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2020

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: 03/31/2022
• Device Catalogue Number: 0500306E
• Device Lot Number: 19CU01021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Device Age: MO
• Initial Date Received by Manufacturer: 11/25/2019
• Supplement Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 100