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 11/19/2018

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 reported a dialyzer blood leak that occurred within five minutes of the patient's hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak and visibly observed in the dialyzer.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 240 ml.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 reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: concomitant medical products and device evaluated by mfr plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, delamination was observed on both ends of the dialyzer which caused the reported failure.Delamination on the cavity id end extended from approximately 20 degrees to 95 degrees and 230 degrees to 350 degrees (two delaminations on one side) and delamination on the non-cavity id end extended from approximately 10 degrees to 130 degrees all with the dialysate ports situated at 0 degrees.Further examination of the fiber bundle 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 conducted by the manufacturer.There was one nonconformance noted on the reported lot regarding exceeding 4% bubble point scrap rate on dialyzer line 7.Proper functioning of the bubble point test system was verified at regular intervals.Additional samples were requested.All samples passed testing and met specification for release.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.The investigation into the cause of the complaint was able to confirm the reported event.

• 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
• MDR Report Key: 8138607
• MDR Text Key: 129507335
• Report Number: 1713747-2018-00481
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• 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: 01/22/2019

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: 08/31/2021
• Device Catalogue Number: 0500318E
• Device Lot Number: 18KU07023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2018
• Device Age: MO
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES