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 Problems Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)

Event Date 12/29/2019

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 reported that an external dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed on unspecified are of the dialyzer.A blood test strip was used to test for the presence of blood, and the result was negative.It was confirmed that the machine, a fresenius 2008 k , alarmed appropriately with a blood leak alert.Fresenius bloodlines were used for the treatment.No damage was identified on the dialyzer.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; the estimated blood loss (ebl) was not captured in the clinic¿s incident report.Follow-up with the clinic¿s charge nurse confirmed there was no patient injury, no adverse events, and no medical intervention as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.

Manufacturer Narrative

Corrected information: h2, h6 patient code- inadvertently omitted h2 for the correction on supplemental #2 (transcription error).

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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.

• 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: 10882273
• MDR Text Key: 222628320
• Report Number: 1713747-2020-00475
• 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,Followup,Followup
• Report Date: 12/07/2020

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: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 19LU01018
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 11/02/2020
• Initial Date FDA Received: 11/22/2020
• Supplement Dates Manufacturer Received: 11/23/2020; 12/03/2020; 12/04/2020
• Supplement Dates FDA Received: 12/01/2020; 12/04/2020; 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008K MACHINE.; FRESENIUS BLOODLINE.