MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F18NRE DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0500308E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/30/2020
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 a dialyzer blood leak occurred 20 minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was confirmed to be internal and visually observed.The machine, a fresenius 4008s machine, alarmed appropriately with a blood leak alarm.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was able to complete treatment that day on the same machine with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint device was not returned to the manufacturer, preventing a physical evaluation from being performed.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.Since a physical evaluation could not be performed, the reported issue could not be confirmed.Furthermore, its cause could not be determined.

• Brand Name: OPTIFLUX F18NRE 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: 10696485
• Report Number: 1713747-2020-00406
• Device Sequence Number: 14267657
• Product Code: FJI
• UDI-Device Identifier: 00840861100088
• UDI-Public: 00840861100088
• 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): 11/16/2020

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: 09/30/2021
• Device Model Number: 0500308E
• Device Catalogue Number: 0500308E
• Device Lot Number: 18LU01002
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/15/2020
• 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 BLOODLINES.; FRESENIUS 4008S MACHINE; FRESENIUS BLOODLINES
• Patient Age: 76 YR
• Patient Weight: 58