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 12/15/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility inventory manager reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.The facility administrator confirmed during follow-up that the blood leak occurred approximately 1 hour and 40 minutes after the initiation of treatment.The blood leak was noted as being an internal blood leak that was visually observed inside the dialyzer.The dialysate inside the dialyzer turned a pinkish color.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient did not complete treatment that day.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d10, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The sample was subjected to a laboratory bubble point leak test.The test passed possibly due to the presence of coagulated blood.The dialyzer sample was then subjected to destructive disassembly for further visual examination.A fiber fragment was identified at approximately 350 degrees on the non-cavity id end with the ports positioned at 0 degrees.The fiber fragment was flush with the potting surface under magnification (x30).The opposing end of the fiber fragment was not found.There was no other damage or irregularities visually noted on the dialyzer.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.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: 11098550
• MDR Text Key: 227522303
• Report Number: 1713747-2020-00536
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

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: 09/30/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 20LU06010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Device Age: MO
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/25/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Weight: 75