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

Catalog Number	0500318N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/07/2023
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 registered nurse (rn) reported that an internal dialyzer blood leak occurred at the very beginning of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The rn was standing in front of the machine monitoring the start of the treatment when they noticed blood outside the fibers at the top of the dialyzer (in the header).The rn stopped the blood pump before blood could reach the blood leak detector.The machine, a fresenius 2008t, did not produce a blood leak alarm.The rn reported that the blood had not traveled to the other end of the dialyzer when the leak was caught.A blood leak test strip was used to test the dialysate for blood, and it tested positive.No physical damage was observed on the dialyzer.The patient¿s blood was not returned following the event; estimated blood loss (ebl) was 250 ml.The patient¿s treatment was completed after they were restarted with new supplies on the same machine.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 reportedly available to be returned for manufacturer evaluation.
Event or Problem Description
A user facility registered nurse (rn) reported that an internal dialyzer blood leak occurred at the very beginning of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The rn was standing in front of the machine monitoring the start of the treatment when they noticed blood outside the fibers at the top of the dialyzer (in the header).The rn stopped the blood pump before blood could reach the blood leak detector.The machine, a fresenius 2008t, did not produce a blood leak alarm.The rn reported that the blood had not traveled to the other end of the dialyzer when the leak was caught.A blood leak test strip was used to test the dialysate for blood, and it tested positive.No physical damage was observed on the dialyzer.The patient¿s blood was not returned following the event; estimated blood loss (ebl) was 250 ml.The patient¿s treatment was completed after they were restarted with new supplies on the same machine.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 reportedly available to be returned for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The device was returned with the corporate provided blood port and adapter caps attached.The fibers were wet with blood throughout the device.During gross visual examination, wicking polyurethane (pu) was found on both ends of the dialyzer.Further visual examination of the device did not identify any other damage or irregularities.The sample was not subjected to a laboratory leak test as wicking pu is known to affect the integrity of the dialyzer.The investigation into the complaint was able to confirm the reported event.The probable cause for this failure to occur is during the manufacturing process as a result of the potting centrifuge halting before the pu is fully cured.If this occurs, the pu will wick down into the fibers.
Event or Problem Description
A user facility registered nurse (rn) reported that an internal dialyzer blood leak occurred at the very beginning of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The rn was standing in front of the machine monitoring the start of the treatment when they noticed blood outside the fibers at the top of the dialyzer (in the header).The rn stopped the blood pump before blood could reach the blood leak detector.The machine, a fresenius 2008t, did not produce a blood leak alarm.The rn reported that the blood had not traveled to the other end of the dialyzer when the leak was caught.A blood leak test strip was used to test the dialysate for blood, and it tested positive.No physical damage was observed on the dialyzer.The patient¿s blood was not returned following the event; estimated blood loss (ebl) was 250 ml.The patient¿s treatment was completed after they were restarted with new supplies on the same machine.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 reportedly available to be returned for manufacturer evaluation.

• 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: 17997486
• Report Number: 0001713747-2023-00731
• Device Sequence Number: 15083048
• Product Code: KDI
• UDI-Device Identifier: 00840861100125
• UDI-Public: 00840861100125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 01/19/2024

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: 04/30/2026
• Device Catalogue Number: 0500318N
• Device Lot Number: 23DU04020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2023
• Supplement Date Received by Manufacturer: 11/07/2023; 01/09/2024
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/14/2023; 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2023
• 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 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Weight: 57 KG