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	02/12/2021
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 biomedical technician (biomed) reported that a leak occurred during a patient¿s hemodialysis (hd) treatment.The biomed reported that the leak was coming from the blue hansen connector.The machine being used was reported to be a gambro phoenix.Additional information was obtained through follow up with the biomed.The biomed stated that the leaking began during the priming stage.It was confirmed that the leak was noted by the staff.However, the leak (reported to be just ¿drops¿) was not significant and there were no reported machine alarms.As a result, the staff elected to proceed with the treatment.During the treatment, the leaking continued.Although the dialyzer was leaking during treatment, the biomed stated there was no blood loss.The only fluid that leaked from the device was dialysate.There were no recorded machine alarms or pressure issues.The patient was able to complete treatment with the original dialysis set-up.Gambro bloodlines were being utilized during the treatment and it was confirmed that the machine was a gambro phoenix.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The actual complaint device was reported to be available for manufacturer evaluation.
Event or Problem Description
A user facility biomedical technician (biomed) reported that a leak occurred during a patient¿s hemodialysis (hd) treatment.The biomed reported that the leak was coming from the blue hansen connector.The machine being used was reported to be a gambro phoenix.Additional information was obtained through follow up with the biomed.The biomed stated that the leaking began during the priming stage.It was confirmed that the leak was noted by the staff.However, the leak (reported to be just ¿drops¿) was not significant and there were no reported machine alarms.As a result, the staff elected to proceed with the treatment.During the treatment, the leaking continued.Although the dialyzer was leaking during treatment, the biomed stated there was no blood loss.The only fluid that leaked from the device was dialysate.There were no recorded machine alarms or pressure issues.The patient was able to complete treatment with the original dialysis set-up.Gambro bloodlines were being utilized during the treatment and it was confirmed that the machine was a gambro phoenix.There was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The actual complaint device was reported to be available for manufacturer evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.Blood port caps from the manufacturing plant were returned attached to the dialyzer.The fibers were wet.During the visual examination, polyurethane (pu) was noted on both distal tips of the dialysate ports.The sample was subjected to a laboratory leak test where there were no leaks detected.No other damage or irregularities were noted on the returned sample.The user facility provided two photos for review.The first photo shows an up-close view of half of a dialyzer on its side.The second photo shows an up-close view of the port where there appears to be pu at the port.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.Although a leak was not replicated during testing, it is known that pu at the port can cause a leak.Therefore, the investigation into the complaint was able to confirm the reported event.

• 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: 11408367
• Report Number: 1713747-2021-00063
• Device Sequence Number: 3483922
• Product Code: FJI
• UDI-Device Identifier: 00840861100026
• UDI-Public: 00840861100026
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Device Age: MO
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1