MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F16NRE DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	0500306E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
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 nurse reported that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.It was reported that the blood was observed in the venous heard cap of the dialyzer.The nursing staff was able to detect the leak.The machine, a fresenius 4008's, alarmed appropriately with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were not used.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment.Despite the blood leak, it was reported that there was no blood loss as the blood was returned to the patient.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 not available to be returned for a manufacturer evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.A photo and video were provided.The video was 15 seconds showing what appears to be the blood leak in the bottom bell housing.The photo shows the same end of the dialyzer connected to the machine with blood in the fibers.The cause for the possible blood leak cannot be determined from the video/photo.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.During the lot history review it was noted that there was one other complaint reported against the lot.The complaint addresses foreign matter found in the dialyzer (no sample).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 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) 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 internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.It was reported that the blood was observed in the venous heard cap of the dialyzer.The nursing staff was able to detect the leak.The machine, a fresenius 4008s, alarmed appropriately with a blood leak alert.Fresenius combi set bloodlines were being utilized for the treatment.Blood test strips were not used.No damage was identified on the dialyzer prior to use.Immediately following the event, the patient was re-setup with new supplies on a different machine where they were able to complete treatment.Despite the blood leak, it was reported that there was no blood loss as the blood was returned to the patient.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 not available to be returned for a manufacturer evaluation as it was reportedly discarded.

• Brand Name: OPTIFLUX F16NRE 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
• MDR Report Key: 12291421
• Report Number: 1713747-2021-00257
• Device Sequence Number: 14618637
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 10/31/2022
• Device Model Number: 0500306E
• Device Catalogue Number: 0500306E
• Device Lot Number: 19NU01001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 63