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	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: 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 a dialyzer leaked immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The rn visually observed that the dialyzer leaked from two locations.The first leak occurred two inches below the header cap of the dialyzer.The second leak occurred within a fiber.The dialyzer leaks were confirmed to be internal.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: h3 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 non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.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.
Event or Problem Description
A user facility registered nurse (rn) reported that a dialyzer leaked immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The rn visually observed that the dialyzer leaked from two locations.The first leak occurred two inches below the header cap of the dialyzer.The second leak occurred within a fiber.The dialyzer leaks were confirmed to be internal.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

• 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
• MDR Report Key: 11543465
• Report Number: 1713747-2021-00091
• Device Sequence Number: 11703295
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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 faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 01/31/2023
• Device Model Number: 0520161A
• Device Catalogue Number: 0520161A
• Device Lot Number: 20AU04017
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 7 YR
• Patient Weight: 22