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	05/01/2020
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
It was reported that about 3 minutes into a patient's hemodialysis (hd) treatment, the hd machine alarmed with a blood leak detected alarm.It was reported that there was visible blood within the dialyzer.It was reported that the patient had to be rinsed back and restarted on a new machine.Additional information was requested but to date, has not been provided.
Event or Problem Description
Additional information was received: upon follow-up, the user facility contact stated that a fresenius 2000k2 machine was being used during the event.Blood test strips were used and tested positive for the presence of blood.It was reported the leak was internal and there was no defect or damage noted on the dialyzer.Although it was originally unknown if the patient lost blood, it was confirmed there was no blood loss as the patient's blood was rinsed back successfully.There was no patient injury, adverse event, or medical intervention required as a result of the reported event.The patient was able to complete treatment with a new setup on the same machine.The dialyzer was reported to be available for return to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as, to date, 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 non-acceptance, 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.
Additional Manufacturer Narrative
Additional information: d10, h3, h6.Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The returned sample was subjected to a laboratory bubble point test.A leak was detected on the cavity id end of the dialyzer located at approximately 90°, with the dialysate ports situated at 0°.The dialyzer was disassembled for further evaluation and a fiber fragment was identified in the same area the leak was identified (at approximately 90° on the cavity id end).The fiber fragment measured approximately 0.07 mm in length.The opposing end of the fiber was unable to be located.Further examination of the fiber bundle did not identify any other damage or irregularities.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There were two approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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.The investigation into the complaint was able to confirm the reported event.

• 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: 10089793
• Report Number: 1713747-2020-00202
• Device Sequence Number: 2924922
• Product Code: FJI
• UDI-Device Identifier: 00840861100071
• UDI-Public: 00840861100071
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K043244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 07/31/2022
• Device Model Number: 0500306E
• Device Catalogue Number: 0500306E
• Device Lot Number: 19JU01003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Device Age: MO
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 05/27/2020; 06/05/2020; 07/27/2020
• Initial Report FDA Received Date: 05/26/2020
• Supplement Report FDA Received Date: 06/03/2020; 06/09/2020; 07/30/2020
• 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 2000K2 MACHINE; FRESENIUS BLOODLINES
• Patient Age: 18 YR
• Patient Weight: 49