MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/11/2019

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 registered nurse (rn) reported that an external dialyzer blood leak occurred approximately one hour into a patient¿s hemodialysis (hd) treatment.Blood was observed leaking from the header end cap of the dialyzer.It was reported that the machine, a fresenius 2008t, did not alarm.Blood leak test strips were used to test for the presence of blood in the machine, and they tested negative.There was no reported damage found on the dialyzer.The patient¿s estimated blood loss (ebl) was less than 50 ml.The rn 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¿s treatment was halted immediately after the leak was observed, and their blood was subsequently returned.The patient completed treatment after being setup with new supplies on the same machine.The complaint device was available to be returned for a physical evaluation.

Manufacturer Narrative

Correction: d10; the complaint device was received by the manufacturer on 01/10/2020.

Manufacturer Narrative

Additional information: d10, h3.Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, the fibers were wet upon return and there was evidence of blood exposure.A pu sliver was observed under the o-ring on the cavity id end.No other defects or irregularities were visually observed on any of the molded dialyzer components.The returned sample was subjected to a laboratory bubble point test.An external leak was detected from the cavity id end.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.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; director, site quality; 475 west 13th street; ogden UT 84404
• MDR Report Key: 9536118
• MDR Text Key: 190706933
• Report Number: 1713747-2019-00397
• 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,Followup
• Report Date: 02/06/2020

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: 09/30/2022
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 19LU07019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Device Age: MO
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/22/2020; 02/06/2020
• Supplement Dates FDA Received: 01/30/2020; 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Age: 45 YR
• Patient Weight: 94