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

Catalog Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the plant¿s investigation.

Event Description

A user facility nurse reported that a blood leak occurred during a patient's hemodialysis (hd) treatment.The machine alarmed as appropriate and blood test strips were used and positively confirmed the presence of blood.No dialyzer defect or damage was visible.The patient¿s estimated blood loss (ebl) was reportedly unknown.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up of supplies on a different machine.The complaint device has been made available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The device was returned to the manufacturer for physical evaluation.A visual examination of the returned device did not find any damage or irregularities.There was no visible coagulated blood within the dialysate compartment or on the circumference of the fiber bundle, however, coagulated blood was observed on both ends of the dialyzer between the screw flange and the potting cut surface.Gross visual examination of sample did not identify any fiber fragments or any kinked, broken, looped, or damaged fibers on the outer perimeter of the fiber bundle.There were no cracks or damage noted on the molded components.The returned device was subjected to a laboratory bubble point test and no leaks were detected, possibly due to coagulated blood.The dialyzer was subjected to a destructive disassembly for further visual examination of the polyurethane (pu) cut surfaces.There was no visual damage, irregularities, or separations identified.The fiber bundle was removed from the dialyzer housing and inspection of the inferior pu surfaces did not identify any damaged, kinked, looped, or irregular fibers or voids.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.The investigation into the cause of the reported problem was not able to confirm the reported leak.The testing of the returned sample could not reveal a probable cause for the customer complaint.Therefore, the complaint is not confirmed.

• Brand Name: OPTIFLUX 160NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7016358
• MDR Text Key: 92616543
• Report Number: 1713747-2017-00358
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17HU01005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 12/01/2017
• Supplement Dates FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1