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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
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 user facility clinic manager (cm) reported that an internal dialyzer blood leak occurred approximately three minutes into a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed in the dialysate compartment of the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Fresenius bloodlines were used for the treatment.Blood leak test strips were used to test for the presence of blood, and they tested positive.There was no reported damage identified on the dialyzer.After the machine alarmed, treatment was halted and the patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was approximately 150 ml.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 patient was able to complete treatment after being set up with new supplies on a different machine.The dialyzer was reportedly available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
H3 plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.Although it was indicated the sample is available, no sample has been provided for evaluation.The third party carrier's website was reviewed, and it was verified that the provided shipping materials were sent to the customer and subsequently received.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.

• 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: 9554442
• Report Number: 1713747-2020-00007
• Device Sequence Number: 11271661
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (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): 01/30/2020

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: 04/30/2022
• Device Model Number: 0500306E
• Device Catalogue Number: 0500306E
• Device Lot Number: 19DU01001
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 01/30/2020
• 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 BLOODLINES
• Patient Age: 63 YR
• Patient Weight: 127