MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/16/2020

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 clinic manager (cm) reported that an internal dialyzer blood leak occurred one hour and fifteen minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be visually observed.A blood test strip was used and tested positive for the presence of blood.It was confirmed that the machine, a fresenius 2008k2, alarmed appropriately with a blood leak alert.No damage was identified on the dialyzer.Fresenius bloodlines were also being utilized for the treatment.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was 200 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on the same machine.The dialyzer was reported to be available for a manufacturer evaluation.

Manufacturer Narrative

Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port caps and adapter caps were returned attached to the dialyzer.There was blood noted throughout the dialyzer and in both head caps.There was no damage noted on the returned sample.A laboratory bubble point leak test was performed on the returned sample.There were no leaks detected, possibly due to the presence of coagulated blood.The dialyzer was then subjected to destructive disassembly for further visual examination.A fiber fragment was identified at approximately 280° on the cavity id end, with the dialysate ports positioned at 0°.The fiber fragment extended from the potting surface measuring approximately 0.15 mm in length under magnification (x20).The opposing end of the fiber fragment was not located.Further examination of the complaint device did not identify any other damage or irregularities.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then 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 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; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 11072233
• MDR Text Key: 223711172
• Report Number: 1713747-2020-00530
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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: 08/31/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 20KU06010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Device Age: MO
• Initial Date Manufacturer Received: 12/17/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K2 MACHINE; FRESENIUS BLOODLINES
• Patient Age: 77 YR
• Patient Weight: 76