MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility patient care technician (pct) reported that an internal blood leak occurred shortly after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed for blood leak and there was a split visibly seen near the top inside of the dialyzer.Blood test strips were used and positively confirmed the presence of blood.The patient¿s estimated blood loss (ebl) was noted as being approximately 100ml as the patient¿s blood was not returned.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 was stated to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information and device evaluation: 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 blood residue between the polyurethane cut surface and the screw flange on both ends of the dialyzer.A single potted fiber fragment was observed at approximately 350° on the non-cavity id end with the dialysate ports at 0°.No other damage or irregularity was noted on the returned sample.The dialyzer was subjected to a laboratory bubble point test and an internal leak was detected from a single fiber which emanated a steady flow of bubbles on the non-cavity id end potting cut surface where the single fiber was observed earlier during the visual examination.The dialyzer was then subjected to destructive disassembly.Upon extraction of the fiber bundle, the single fiber was located and viewed under magnification (20x) on the microscope.The fiber was observed to be indented and damaged at multiple locations.Further examination of the fiber bundle did not identify any other damage or irregularities.An investigation of the device manufacturing records was conducted by the manufacturer.There were two approved temporary deviation notices noted on the lot which were unrelated to the reported complaint 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 investigation into the cause of the reported problem was able to confirm the failure mode.There was a confirmed internal leak on the non-cavity id end of the dialyzer.The complaint has been deemed confirmed.

• Brand Name: OPTIFLUX 180NRE 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: 7151657
• MDR Text Key: 96024026
• Report Number: 1713747-2017-00412
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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,Followup
• Report Date: 02/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Device Catalogue Number: 0500318E
• Device Lot Number: 17NU03007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 01/03/2018; 02/19/2018
• Supplement Dates FDA Received: 01/16/2018; 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2017
• 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
• Patient Age: 62 YR
• Patient Weight: 77