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 in both headers of the cavity and non-cavity id ends of the dialyzer.There was a noted polyurethane (pu) delamination on the cavity id end of the dialyzer from approximately 310º to 70º with the dialysate ports at 0º.The delamination manifested as separation of the pu potting material from the dialyzer housing wall.The delamination in the pu potting extended under the silicone o-ring.No other damage or irregularities were noted on the dialyzer.The returned sample was not subjected to a laboratory bubble point test as the delamination causes leak paths from the blood side into the dialysate chamber.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 able to confirm the failure mode.There was a confirmed delamination on the cavity id end of the dialyzer.The complaint has been deemed confirmed.

Event Description

A user facility clinic manager 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 and blood was visually observed in the dialyzer fibers.Blood was also reportedly seen within the hansen connector at the arterial connection.Blood test strips were not used.It was reported that there was an indented area in the dialyzer at approximately 1-1.5 cm below the end cap to the arterial end of the dialyzer.The patient¿s estimated blood loss (ebl) was noted as being approximately 100-250 ml 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 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: 7082274
• MDR Text Key: 94806621
• Report Number: 1713747-2017-00385
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• 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: 17HU01001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• 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: 06/01/2017
• 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: 65 YR
• Patient Weight: 89