MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500320E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/25/2021

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 inventory manager reported that a dialyzer leak occurred during a patient¿s hemodialysis (hd) treatment.Upon follow up it was confirmed that the machine alarmed with a positive blood detected message.The blood leak was noted as being an internal blood leak.The leak was visually observed as minimal blood loss.Blood leak test strips were used and tested positive for the presence of blood.The patient¿s estimated blood loss (ebl) was unknown there was no patient injury, adverse events, or medical intervention required as a result of this event.The patient had an hour left of treatment and was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be discarded and not available to be returned to the manufacturer for evaluation.

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 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 200NRE 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: 11325416
• MDR Text Key: 253062882
• Report Number: 1713747-2021-00047
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• 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
• Report Date: 02/25/2021

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: 11/30/2023
• Device Model Number: 0500320E
• Device Catalogue Number: 0500320E
• Device Lot Number: 20PU04009
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 01/25/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1