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	07/27/2020
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 user facility nurse reported that an internal dialyzer blood leak occurred approximately one minute into a patient¿s hemodialysis (hd) treatment.Blood was visually observed on the outside of the dialyzer filter.The machine, a fresenius 4008s, alarmed with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were not used.No defects were identified on the dialyzer prior to use.However, after the blood leak occurred, broken fiber membranes were identified.The treatment was immediately stopped following the event.The patient completed their treatment after being re-setup with new supplies on a different machine.The patient¿s estimated blood loss (ebl) was approximately 50 ml.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.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was 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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

• 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: 10391743
• Report Number: 1713747-2020-00322
• Device Sequence Number: 2004665
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2020

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: 07/31/2022
• Device Model Number: 0500306E
• Device Catalogue Number: 0500306E
• Device Lot Number: 19JU01003
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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 4008S MACHINE; FRESENIUS COMBI SET BLOODLINES
• Patient Age: 33 YR
• Patient Weight: 62