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	Blood Loss (2597)
Date of Event	07/31/2020
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 in (b)(6) reported to fresenius (b)(4) technical services that after 5 minutes of initiating hemodialysis (hd) treatment the nursing staff observed blood leaking from the arterial head cap of the dialyzer.There was no adverse event, injury, nor medical intervention required as a result of the reported event.The estimated blood loss was 250ml.The patient's blood flow rate was 350 ml/min, and dialysis flow rate was 500.Patient has been receiving hd treatments 3 times a week since (b)(6) 2020.The dialyzer was replaced and the hd treatment was completed on the same hd system.There are no sample available to return.
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 were no deviation notices (dn) reported on the lot.There were three other complaints reported on the lot: two involving a broken head cap (one confirmed with a sample and the other unconfirmed with provided pictures) and one complaint addressing an internal dialyzer leak (unconfirmed with photo documentation).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 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: 10435331
• Report Number: 1713747-2020-00335
• Device Sequence Number: 2948579
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 18LU01001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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
• Patient Age: 31 YR
• Patient Weight: 51