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	11/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility nurse reported that an external blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.It was initially reported that ¿a crack¿ was found on the clic blood chamber.Upon follow-up, it was reported that a couple of blood droplets were identified on the hd machine which were traced to an external leak from the dialyzer end connection of the clic blood chamber.An external blood leak was alleged.Reportedly, the patient¿s blood had sealed itself off at the site of the leak.As a result, the treatment was continued and completed with the same supplies and on the same machine.Despite the initial allegation of physical damage, follow-up confirmed that no cracks were visually identified on the clic blood chamber.There were no machine alarms associated with the reported failure.The patient¿s estimated blood loss (ebl) was 5 ml.There was no report of any patient adverse effects or required medical intervention.As a prophylactic measure, the patient was administered an antibiotic infusion x1 (further details on this were not provided).The dialyzer was not available to be returned for physical evaluation.However, a photo of the device connected to the clic blood chamber was provided for review.
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.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.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 nurse reported that an external blood leak occurred two hours into a patient¿s hemodialysis (hd) treatment.It was initially reported that ¿a crack¿ was found on the clic blood chamber.Upon follow-up, it was reported that a couple of blood droplets were identified on the hd machine which were traced to an external leak from the dialyzer end connection of the clic blood chamber.An external blood leak was alleged.Reportedly, the patient¿s blood had sealed itself off at the site of the leak.As a result, the treatment was continued and completed with the same supplies and on the same machine.Despite the initial allegation of physical damage, follow-up confirmed that no cracks were visually identified on the clic blood chamber.There were no machine alarms associated with the reported failure.The patient¿s estimated blood loss (ebl) was 5 ml.There was no report of any patient adverse effects or required medical intervention.As a prophylactic measure, the patient was administered an antibiotic infusion x1 (further details on this were not provided).The dialyzer was not available to be returned for physical evaluation.However, a photo of the device connected to the clic blood chamber was provided for review.

• 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: 12913704
• Report Number: 1713747-2021-00450
• Device Sequence Number: 11998495
• Product Code: FJI
• UDI-Device Identifier: 00840861100019
• UDI-Public: 00840861100019
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/28/2021

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: 08/31/2024
• Device Model Number: 0520165A
• Device Catalogue Number: 0520165A
• Device Lot Number: 21KU04005
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 12/26/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLIC BLOOD CHAMBER; CLIC BLOOD CHAMBER
• Patient Age: 10 MO
• Patient Sex: Male
• Patient Weight: 9 KG