MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; 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	06/21/2018
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 clinical manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak, and it was visually observed as a crack near the arterial side of the dialyzer.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.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 and treatment was completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: as no lot number was provided for this complaint, a sap search was performed to obtain all lots with the reported catalog number delivered to the customer in the three months prior to the complaint occurrence date.A lot history review was performed for each lot.During the review, the ogden investigator noted that four of the 12 reviewed lots had complaints.None of the leaks previously reported mention a crack in the dialyzer.The production record for each lot with the reported catalog number identified on the patient¿s sap delivery search was reviewed.Nine lots had one approved temporary dns and three lots had two approved temporary dns.They are unrelated to the reported complaint event.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 lots 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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: OPTIFLUX 160NRE 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: 7639666
• Report Number: 1713747-2018-00238
• Device Sequence Number: 1719279
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K002761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2018

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 Catalogue Number: 0500316E
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/18/2018; 07/23/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/18/2018; 07/30/2018
• 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 2008T HEMODIALYSIS MACHINE; FRESENIUS BLOODLINES
• Patient Age: 48 YR
• Patient Weight: 61