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

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/21/2017

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 nurse reported that an internal dialyzer blood leak occurred approximately three minutes after initiation of the patient's hemodialysis (hd) treatment.The machine alarmed for blood leak.Blood test strips were not used because the blood leak was visually observed in the dialyzer.No dialyzer damage was visible.The patient¿s estimated blood loss (ebl) was noted as being more than 100 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 the same machine.The complaint device was available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the device was returned to the manufacturer for physical evaluation.A visual examination of the device noted that the fiber bundle was wet and revealed the presence blood residue between the polyurethane cut surface and the screw flanges on both ends of the dialyzer.Coagulated blood was observed in the dialysate compartment and on the cavity id end of the dialyzer.During examination, it was noted that there was a fiber at approximately 140º on the cavity id end with the dialysate ports at 0º from which the reported leak may have originated.No other damage or irregularity was noted on the returned sample.The dialyzer was subjected to a laboratory bubble point test.The results did not detect any leak, which was possibly due to the amount of coagulated blood in the blood compartment.Following the test, the dialyzer was subjected to destructive disassembly.Upon removal of the fiber bundle, it was confirmed that there was a fiber from which the reported leak may have originated at approximately 140° with the dialysate ports at 0°, as seen in the earlier visual inspection.No other damage or irregularities were identified.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There was one approved temporary deviation notice noted on the lot, which was 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-conformance, 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 defective fiber on the 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: 7124585
• MDR Text Key: 95793842
• Report Number: 1713747-2017-00402
• 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
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17LU02016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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: 52 YR
• Patient Weight: 65