MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500320E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/30/2017

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 with evidence of blood contamination.The fibers were streaked with blood residue and blood was noted within the dialysate compartment.Coagulated blood was observed in both heads of the cavity and non-cavity id ends of the dialyzer.Gross visual examination of the returned device identified a delamination on the non-cavity id end which extended from approximately 330º to 30º with the dialysate ports at 0º.The delamination manifested as separation of the polyurethane (potting material) from the dialyzer housing wall.The delamination in the polyurethane potting extended under the silicone o-ring.There were no other defects or irregularities visually identified on the fiber bundle or any of the molded dialyzer components.There are no other complaints reported on this lot.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.The lot had two approved temporary deviation notices (dn) that were unrelated to the reported complaint.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.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 non-cavity id end of the dialyzer.The complaint has been deemed confirmed.

Event Description

A user facility nurse reported that a blood leak occurred immediately after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed for blood leak and blood was visible internal to the dialyzer head and also within the effluent.Therefore, blood test strips were not used to confirm the presence of blood.No dialyzer defect or damage was visible.The patient¿s estimated blood loss (ebl) was noted as being approximately 280-290 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 200NRE 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: 7052096
• MDR Text Key: 93440724
• Report Number: 1713747-2017-00371
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• 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: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 0500320E
• Device Lot Number: 17KU04007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2017
• 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: 84