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 11/10/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the device was returned to the manufacturer for physical evaluation.A visual examination of the returned device noted that the fiber bundle was wet and revealed the presence blood residue.Coagulated blood was observed between the polyurethane (pu) cut surface and the screw flanges on both ends of the dialyzer.Gross visual examination of the returned device identified no defects or irregularities on the fiber bundle or any of the molded components.The dialyzer was subjected to a laboratory bubble point test and failed.An internal leak was observed on the cavity id end potting cut surface at approximately 170° with the dialysate ports at 0.The sample was then subjected to destructive disassembly to isolate the observed leak.Upon removal of the fiber bundle, a short fiber was noted on the circumference of the fiber bundle on the cavity id end at approximately 170° with the dialysate ports at 0°, the same location where the bubble point test indicated a leak.There was no other damager or irregularities identified during destructive disassembly.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were two approved temporary deviation notices (dn) noted on the lot which were unrelated to the reported event.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 able to confirm the failure mode.There was a confirmed internal leak on the cavity id end of the dialyzer.The complaint has been deemed confirmed.

Event Description

A user facility nurse reported that a blood leak occurred right after the initiation of the patient's hemodialysis (hd) treatment.The blood leak was noted as being an internal dialyzer leak.The machine alarmed for blood leak.There was no visible blood leak and no visible defect with the dialyzer.Blood test strips were used on the dialysate which confirmed the presence of blood.The patient¿s estimated blood loss (ebl) was noted as being approximately 250 ml as the patient¿s blood was not returned.The patient reportedly felt a little tired but there were no patient serious adverse effects experienced and no medical intervention was required for the reported tiredness because of this event.The patient completed treatment with a new set-up of supplies on the same machine.The complaint device was available to be returned to the manufacturer for evaluation.

• 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: 7094868
• MDR Text Key: 95497263
• Report Number: 1713747-2017-00387
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0500316E
• Device Lot Number: 17JU01005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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