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 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility clinical manager reported that a dialyzer blood leak occurred 15 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an external blood leak.The leak was visually observed.The patient¿s estimated blood loss (ebl) was approximately 250ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was returned to the manufacturer for analysis.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, coagulated blood was observed within both header caps, and there was coagulated blood within the threads of the non-cavity id end header cap.There was also blood present on the outside of the housing on the non-cavity id end.The dialyzer was subjected to an external leak test and passed possibly due to coagulated blood.The header caps were removed for further visual evaluation.On the non-cavity id end, the o-ring was damaged.The damage was in the form of a gouge on the surface of the o-ring and was facing the pu potting surface.The gouge may have prevented a secure seal between the potting cut surface and the o-ring.No damage or irregularity was observed on the cavity id end or any other part of the dialyzer.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.The investigation into the cause of the complaint was able to confirm the reported event.

• 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
• MDR Report Key: 8160894
• MDR Text Key: 130331040
• Report Number: 1713747-2018-00487
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 0500316E
• Device Lot Number: 18HU06020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Device Age: MO
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Age: 72 YR
• Patient Weight: 32