MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT DIALYZER, OPTIFLUX ULTRA F160, ASSY; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	0500416E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported an internal dialyzer blood leak that occurred immediately in a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was used and tested positive.No visible damage was observed on the dialyzer.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 50 ml.The rn 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 reportedly not available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As no lot number was provided by the complainant, a delivery search was performed to identify all lot numbers with the reported catalog number shipped to the complainant in the three months prior to the occurrence date.There were no lot identified within this time frame.The search was then extended to find the last lot delivered with the reported catalog number.Again, there were no results; therefore, a lot history review or production record review could not be performed.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 non-conformance/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.
Event or Problem Description
A user facility registered nurse (rn) reported an internal dialyzer blood leak that occurred immediately in a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008k2 machine, alarmed appropriately with a blood leak alarm.A blood leak test strip was used and tested positive.No visible damage was observed on the dialyzer.After the machine alarmed, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 50 ml.The rn 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 reportedly not available to be returned for manufacturer evaluation.

• Brand Name: DIALYZER, OPTIFLUX ULTRA F160, ASSY
• 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: 17243959
• Report Number: 0001713747-2023-00437
• Device Sequence Number: 15127957
• Product Code: KDI
• UDI-Device Identifier: 00840861100187
• UDI-Public: 00840861100187
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K123262
• 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): 08/04/2023

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 Model Number: 0500416E
• Device Catalogue Number: 0500416E
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 47 KG