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

Model Number	0500318N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (biomed) reported a dialyzer blood leak that occurred during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up with the facility.A nurse familiar with the event stated the blood leak occurred approximately two hours and ten minutes into the treatment.The blood leak was reported to be internal.The nurse stated the blood leak was visually observed in the dialysate compartment of the dialyzer.Blood streaks were noted on the outside of the fiber bundle.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.B.Braun bloodlines were being utilized for the treatment.A blood test strip was used, and it tested positive for the presence of blood.No visible damage was observed on the dialyzer.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; their estimated blood loss (ebl) was 250 ml.The nurse 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 completed treatment after being resetup with new supplies on a different machine.The complaint device was not available to be returned for manufacturer evaluation as it was reportedly discarded.
Event or Problem Description
A user facility biomedical technician (biomed) reported a dialyzer blood leak that occurred during a patient¿s hemodialysis (hd) treatment.Additional information was obtained through follow-up with the facility.A nurse familiar with the event stated the blood leak occurred approximately two hours and ten minutes into the treatment.The blood leak was reported to be internal.The nurse stated the blood leak was visually observed in the dialysate compartment of the dialyzer.Blood streaks were noted on the outside of the fiber bundle.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.B.Braun bloodlines were being utilized for the treatment.A blood test strip was used, and it tested positive for the presence of blood.No visible damage was observed on the dialyzer.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; their estimated blood loss (ebl) was 250 ml.The nurse 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 completed treatment after being resetup with new supplies on a different machine.The complaint device was not available to be returned for manufacturer evaluation as it was reportedly discarded.
Additional 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.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of the highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via the nc/capa program, in order to assess and improve our products and processes.Capas for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

• Brand Name: OPTIFLUX 180NR DIALYZER FINISHED ASSMBLY
• Common Device Name: 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
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16097810
• Report Number: 0001713747-2023-00004
• Device Sequence Number: 6669242
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K002277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 0500318N
• Device Catalogue Number: 0500318N
• Device Lot Number: 22KU04015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 131 KG