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 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialyzer.A blood test strip was used to test for the presence of blood, and it tested positive.It was confirmed that the unspecified hd machine alarmed appropriately with a blood leak alert.After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reported to be 200 ml.There was no patient injury, adverse events, and no medical intervention reported as a result of this event.The patient resumed their treatment after being re-setup with new supplies on a different machine.It was noted that the patient was stable when transitioning to the new hd machine.Multiple attempts were made to acquire additional information, however, a response was not received.

Manufacturer Narrative

Patient code replaced (transcription error) 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, non-conformances, deviation, 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: 10882349
• MDR Text Key: 224309914
• Report Number: 1713747-2020-00480
• 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
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2020
• 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: 19LU01017
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1