MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NR 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	08/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A clinic manager reported a patient was connected to the 2008t hd machine when a blood leak was observed from the dialyzer.The 2008t hd machine generated a blood leak alarm approximately 30 minutes after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 175 and the patient¿s blood flow rate (bfr) was 350.The manager stated the bloodlines used were fresenius.The leak was noted as being an internal blood leak within the dialyzer, and no external leak was noted.No damage to the dialyzer or packaging was observed.The patient¿s estimated blood loss (ebl) was unknown.The manager stated a blood leak test strip was used after the incident to check for the presence of blood in the dialysate; the test strip returned a positive result.Per clinic manager no patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient dialyzed 3 times a week and had been on hemodialysis since (b)(6) 2017.The patient was able to complete treatment with new supplies on another machine.The manager stated the sample was discarded and was no longer available for evaluation.
Additional Manufacturer Narrative
Catalog number: 0500316e the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.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-conformance, 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.
Event or Problem Description
A clinic manager reported a patient was connected to the 2008t hd machine when a blood leak was observed from the dialyzer.The 2008t hd machine generated a blood leak alarm approximately 30 minutes after the hd therapy was initiated.The patient¿s dialysate flow rate (dfr) was 175 and the patient¿s blood flow rate (bfr) was 350.The manager stated the bloodlines used were fresenius.The leak was noted as being an internal blood leak within the dialyzer, and no external leak was noted.No damage to the dialyzer or packaging was observed.The patient¿s estimated blood loss (ebl) was unknown.The manager stated a blood leak test strip was used after the incident to check for the presence of blood in the dialysate; the test strip returned a positive result.Per clinic manager no patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient dialyzed 3 times a week and had been on hemodialysis since (b)(6) 2017.The patient was able to complete treatment with new supplies on another machine.The manager stated the sample was discarded and was no longer available for evaluation.

• Brand Name: OPTIFLUX 160NR 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: 6860876
• Report Number: 1713747-2017-00298
• Device Sequence Number: 18863179
• Product Code: KDI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2017

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: 04/30/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17DU06009
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 09/02/2017
• Supplement Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 80