MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSMBLY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	0500316E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2019
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 reported a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being in the external dialysate inflow.The leak was visually observed.Blood leak test strips were not used.The patient¿s estimated blood loss (ebl) was approximately 250ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the same machine (not a fresenius machine) and treatment completed successfully with new supplies.It was confirmed that a sample is not available for return.
Additional Manufacturer Narrative
Correction: mfr site and device manufacture date 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 160NRE DIALYZER FINISHED ASSMBLY
• 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: 8478022
• Report Number: 1713747-2019-00099
• Device Sequence Number: 1019666
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002277
• 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): 05/10/2019

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: 09/30/2021
• Device Catalogue Number: 0500316E
• Device Lot Number: 18LU06013
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/15/2019
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 50