MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F250NRE DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500325E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that at the beginning of a patient's hemodialysis (hd) treatment, the hd machine alarmed with a blood leak alarm.The blood could not be rinsed back to the patient resulting in blood loss less than 200 ml (exact amount not provided).It was reported the blood leak was observed internally.The patient was moved to a new machine to complete treatment.It was reported the dialyzer is available to be returned to the manufacturer for evaluation.The machine was taken out of service after the event.There was no patient injury or adverse event reported at intake.Additional information was requested but to date, has not been provided.

Event Description

Additional information was received on 12/15/2020: the blood leak occurred three minutes into the patient's hemodialysis (hd) treatment.The blood leak was visually observed on the inside of the header cap.It was reported there was a defect/damage noted on the dialyzer, however it was not specified.The patient completed treatment on the same machine with new supplies.It was confirmed the patient did not develop any injury, adverse event, or require medical intervention as a result of the reported event.

Manufacturer Narrative

H3 plant investigation: the reported complaint was not confirmed as to date, the complaint device was not returned for manufacturer evaluation.The third party carriers website was verified with the tracking number and no information was found that the customer returned the sample.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 approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Manufacturer Narrative

H10 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The sample was subject to a laboratory bubble test.A leak was detected at approximately 90° on the cavity id end.The dialyzer was then subjected to a destructive disassembly for further visual examination.Under magnification (20x), a fiber fragment was identified at the same location it leaked during bubble point testing.The fiber fragment measured approximately 2.05 mm in length.There was no other damage or irregularity noted on the returned sample.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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 F250NRE DIALYZER
• 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: 11008961
• MDR Text Key: 221537339
• Report Number: 1713747-2020-00517
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100170
• UDI-Public: 00840861100170
• Combination Product (y/n): N
• PMA/PMN Number: K082414
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 0500325E
• Device Catalogue Number: 0500325E
• Device Lot Number: 20JU04016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Device Age: MO
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES (COMBI SET); FRESENIUS 2008T MACHINE
• Patient Age: 65 YR
• Patient Weight: 103