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	10/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinical manager (cm) reported that a blood leak occurred at the beginning of a patient¿s hemodialysis (hd) treatment.It was reported that blood was seen leaking externally from the venous connector of the combi set bloodline, where the combi set connects with the dialyzer.The cm stated that the venous connector disconnected from the optiflux dialyzer.The machine, a fresenius 2008t hd machine, did not produce any alarms.There were no defects observed on the optiflux dialyzer or on the combi set bloodline, including at the site of the disconnection/leak.The cm said the threading of both devices appeared normal, and the connection was confirmed to be secure prior to treatment initiation.Furthermore, there were no leaks noted during the priming phase.Following the leak, the patient¿s blood was not returned; estimated blood loss (ebl) was 100 ml.The cm 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 the same machine.The dialyzer was not available to be returned for manufacturer evaluation as it was reportedly discarded.
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 clinical manager (cm) reported that a blood leak occurred at the beginning of a patient¿s hemodialysis (hd) treatment.It was reported that blood was seen leaking externally from the venous connector of the combi set bloodline, where the combi set connects with the dialyzer.The cm stated that the venous connector disconnected from the optiflux dialyzer.The machine, a fresenius 2008t hd machine, did not produce any alarms.There were no defects observed on the optiflux dialyzer or on the combi set bloodline, including at the site of the disconnection/leak.The cm said the threading of both devices appeared normal, and the connection was confirmed to be secure prior to treatment initiation.Furthermore, there were no leaks noted during the priming phase.Following the leak, the patient¿s blood was not returned; estimated blood loss (ebl) was 100 ml.The cm 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 the same machine.The dialyzer 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: 15736863
• Report Number: 0001713747-2022-00494
• Device Sequence Number: 2983880
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 03/31/2025
• Device Model Number: 0500318N
• Device Catalogue Number: 0500318N
• Device Lot Number: 22CU04022
• 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: 10/19/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2022
• 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.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 85 KG