MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F8 DIALYZER FINISHED ASSY (CASE); DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	0500164A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2019
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 clinic nurse at a user facility reported that a dialyzer leaked from the membranes during pretreatment setup of a patient¿s hemodialysis treatment.A new dialyzer was used to complete the treatment.A photo of the dialyzer was provided which showed evidence of blood loss.Upon follow up, it was reported that the blood leak occurred one minute after starting treatment.The machine, a fresenius 2008k machine, alarmed appropriately with a blood leak alarm.It was unknown if fresenius bloodlines were used.The blood leak was noted as being an internal blood leak.The patient¿s estimated blood loss (ebl) was approximately 40 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was treatment completed successfully on the same machine with new supplies.The dialyzer was discarded and is not available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Plant investigation: the actual device was returned to the manufacturer for physical evaluation.A gross visual examination was performed and did not reveal any damage, defects or irregularities.As no damage was visually noted, a bubble point test was performed on the returned sample.No leaks were detected.There was no indication of any defect or leak from the fibers (membranes) as reported by the nurse.The lot history review was performed and there were no other reported complaints noted against the lot.The production record was reviewed and there was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.
Event or Problem Description
A clinic nurse at a user facility reported that a dialyzer leaked from the membranes during pretreatment setup of a patient¿s hemodialysis treatment.A new dialyzer was used to complete the treatment.Upon follow up, it was confirmed that there was no blood leak.There was no patient involvement.The patient was treatment completed successfully on the same machine with new supplies.The dialyzer was available to be returned to the manufacturer for physical evaluation.

• Brand Name: F8 DIALYZER FINISHED ASSY (CASE)
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 8905330
• Report Number: 1713747-2019-00265
• Device Sequence Number: 2716321
• Product Code: FJI
• UDI-Device Identifier: 00840861100040
• UDI-Public: 00840861100040
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K870725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2019

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: 02/29/2020
• Device Catalogue Number: 0500164A
• Device Lot Number: 17BU04018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Device Age: MO
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 08/19/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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 2008K MACHINE; FRESENIUS 2008K MACHINE
• Patient Age: 27 YR
• Patient Weight: 50