MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F3 DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520165A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
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 patient care manager (pcm) reported that an internal dialyzer blood leak occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be visually observed in the dialysate compartment of the device.A blood leak test strip was used and tested positive.It was confirmed that the machine, a baxter phoenix, alarmed appropriately with a blood leak alert.No visible damage was identified on the dialyzer.The patient was dialyzing with neonatal bloodlines (manufacturer not specified).After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 64 ml.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 patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reported to be available for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The corporate provided blood port caps and adapter caps were returned attached to the dialyzer.There was blood noted throughout the dialyzer.There was no damage noted on the returned sample.A laboratory bubble point leak test was performed on the returned sample.There were no leaks detected during the test.The dialyzer was then subjected to destructive disassembly for further visual examination.Upon extraction of the fiber bundle, a looped fiber was identified on the cavity id end at approximately 90°, with the dialysate ports situated at 0°.Further examination of the fiber bundle did not reveal any other damage or irregularities.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was then 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.The investigation into the complaint was able to confirm the reported event.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.Vision systems and blood leak reduction capas are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
Event or Problem Description
A user facility patient care manager (pcm) reported that an internal dialyzer blood leak occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be visually observed in the dialysate compartment of the device.A blood leak test strip was used and tested positive.It was confirmed that the machine, a baxter phoenix, alarmed appropriately with a blood leak alert.No visible damage was identified on the dialyzer.The patient was dialyzing with neonatal bloodlines (manufacturer not specified).After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 64 ml.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 patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reported to be available for manufacturer evaluation.Additional information was reported via user facility medwatch # (b)(4).It was reported that blood was also visible in the lines, and in the header of the dialyzer.After the machine alarmed, the pump was stopped and the lines were clamped.
Additional Manufacturer Narrative
The user facility provided the incorrect patient information and event date in the initial reporting.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility patient care manager (pcm) reported that an internal dialyzer blood leak occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.The blood leak was reported to be visually observed in the dialysate compartment of the device.A blood leak test strip was used and tested positive.It was confirmed that the machine, a baxter phoenix, alarmed appropriately with a blood leak alert.No visible damage was identified on the dialyzer.The patient was dialyzing with neonatal bloodlines (manufacturer not specified).After the machine alarmed, the treatment was halted.The patient¿s blood was not returned; estimated blood loss (ebl) was reportedly 64 ml.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 patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was reported to be available for manufacturer evaluation.Additional information was reported via user facility medwatch # (b)(4).It was reported that blood was also visible in the lines, and in the header of the dialyzer.After the machine alarmed, the pump was stopped and the lines were clamped.

• Brand Name: F3 DIALYZER FINISHED ASSY
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12801231
• Report Number: 1713747-2021-00427
• Device Sequence Number: 11897900
• Product Code: FJI
• UDI-Device Identifier: 00840861100019
• UDI-Public: 00840861100019
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K874872
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2021

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: 02/29/2024
• Device Model Number: 0520165A
• Device Catalogue Number: 0520165A
• Device Lot Number: 21BU04023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 12/08/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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
• Patient Age: 12 MO
• Patient Sex: Male
• Patient Weight: 12 KG