MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F160NRE DIALYZER; DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	0500316E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The dialyzer has not been returned for evaluation to date.During the lot history review it was noted that there are no other reported complaints 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.
Event or Problem Description
Clinic nurse reported a dialyzer blood leak one hour into patient's treatment.During follow up a clinic nurse reported that the patient did not require any medical intervention and was moved to another machine to complete dialysis.The machine alarmed and blood was visible in the dialysate.No test strip was used.The blood loss was approximately 200 cc or one complete circuit.The dialyzer was not made available for evaluation.

• Brand Name: OPTIFLUX F160NRE DIALYZER
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 7001137
• Report Number: 1713747-2017-00356
• Device Sequence Number: 1851600
• Product Code: FJI
• UDI-Device Identifier: 00840861100118
• UDI-Public: 00840861100118
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

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: Nurse
• Device Catalogue Number: 0500316E
• Device Lot Number: 17EU06014
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 72