MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500318E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2019
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 nurse reported that a dialyzer blood leak occurred immediately initiating the patient¿s hemodialysis (hd) treatment.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.Additional information was requested, however to date not provided.
Additional Manufacturer Narrative
Correction: d4 and h4.
Additional Manufacturer Narrative
Additional information: d10, h3 plant investigation: the actual device was returned to the manufacturer for physical evaluation.A sample from the reported lot was received and was subjected to a laboratory bubble point test.A leak was detected as a steady flow of bubbles from the cavity id end potting cut surface at approximately 75°, with the dialysate ports situated at 0°.The dialyzer was then disassembled for further evaluation and two potted fiber fragments were identified.The first fiber fragment measured approximately 0.54mm in length and the second fiber measured approximately 0.60mm in length.The opposing ends of each fiber could not be isolated.Further examination of the fiber bundle did not identify any other damage or irregularities.The lot history review was performed and there were no other reported complaints noted against the lot.The production record was reviewed and there was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 9082138
• Report Number: 1713747-2019-00303
• Device Sequence Number: 11438023
• Product Code: KDI
• UDI-Device Identifier: 00840861100194
• UDI-Public: 00840861100194
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2019

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: 05/31/2022
• Device Catalogue Number: 0500318E
• Device Lot Number: 19EU02009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Device Age: MO
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 09/24/2019; 11/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 09/25/2019; 11/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1