MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F4 DIALYZER PRODUCTION ASSY.; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0520161A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
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 clinical manager reported that a dialyzer blood leak occurred approximately 2 hours and 50 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The leak was not visually observed.The machine, a gambro phoenix machine (not a fresenius product), alarmed appropriately with a blood leak alarm.The patient¿s estimated blood loss (ebl) was approximately 82 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient ended treatment early as only 10 minutes of treatment remained at the time of the event.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility clinical manager reported that a dialyzer blood leak occurred approximately 2 hours and 50 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The leak was not visually observed.The machine, a gambro phoenix machine (not a fresenius product), alarmed appropriately with a blood leak alarm.The patient¿s estimated blood loss (ebl) was approximately 82 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient ended treatment early as only 10 minutes of treatment remained at the time of the event.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: a sample from the reported lot number was returned to the manufacturer for physical evaluation.The returned sample was subjected to a laboratory bubble point test.No leaks were detected.The pu distribution on either side of the dialyzer was uneven, but within specification and showed no indication of being compromised or related to the leak report.There was also pu within the cavity id dialysate port, but also would not contribute to an internal or external leak due to the pu location.Dialyzer was then disassembled for further investigation.There were no damages or irregularities noted that would have contributed to an internal leak.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.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.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: F4 DIALYZER PRODUCTION 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: 13480470
• Report Number: 1713747-2022-00041
• Device Sequence Number: 5247309
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• 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
• Report Date (Section B): 03/16/2022

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: 01/31/2023
• Device Model Number: 0520161A
• Device Catalogue Number: 0520161A
• Device Lot Number: 20AU04021
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2020
• 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: 23 MO
• Patient Sex: Male
• Patient Weight: 12 KG