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 Cramp(s) (2193); No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2020

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 hemodialysis (hd) user facility reported a dialyzer blood leak that occurred during a patients hd treatment.Additional information was obtained during follow up with the facilitys clinic manager (cm).The cm stated the blood leak occurred towards the end of the patients treatment, with less than ten minutes remaining.The blood leak was reported to be internal.The cm was not present at the time of the event did not know if the blood leak was visually observed.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius bloodlines were also being used.A blood test strip was used to test for the presence of blood, and it tested positive.There was no reported damage identified on the dialyzer.After the machine alarmed, the treatment was halted.The patients blood was not returned; estimated blood loss (ebl) was approximately 200 ml.The cm stated the patient did not complete their treatment.However, it was 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 dialyzer was not available to be returned for evaluation as it was reportedly discarded after the event.

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.

Manufacturer Narrative

Additional information: b5.

Event Description

Additional information was received which indicated the patient complained of cramping when the machine started alarming with a blood leak message.There was no report of medical intervention.

• 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: 10094645
• MDR Text Key: 198303756
• Report Number: 1713747-2020-00205
• 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
• Report Date: 11/24/2020

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: 02/28/2023
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 20BU06021
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 06/23/2020; 11/02/2020
• Supplement Dates FDA Received: 06/24/2020; 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES
• Patient Age: 48 YR
• Patient Weight: 85