MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX F18NRE DIALYZER FINISHED ASSY; DIALYZER, CAPILLARY, HOLLOW FIBER

Model Number	OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2022
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 medical worker reported that during hemodialysis (hd) treatment there was a blood leak (clot).In a follow up, it was verified that the clot (leak) occurred about 1 hour after starting the hd treatment.The reporter stated that after one hour of starting the treatment the alarm of arterial pressure, air, venous pressure and transmembrane pressure were activated.When the staff made an inspection it was detected that there were clots that caused the treatment to be stopped.Blood test strips were not used.The machine, a fresenius 4008s machine, alarmed appropriately with the alarm.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 300 ml.There was no patient injury or medical intervention required as a result of this event.There was no visible damage to the dialyzer.The treatment was completed the same day with new supplies on the same machine.The device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the reported complaint was not confirmed as 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.A review of the production record was performed.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.There is no recall associated with this complaint.Photographs were provided.The photographs show a dialyzer connected to blood lines, from different angles.There is blood throughout the dialyzer; however, it is difficult to determine if there was a clot present within the dialyzer.There were drops of blood noted on the floor, but the dialyzer and blood lines were disconnected, it is unknown if the blood was from the disconnection as there was not report of an external leak.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 for vision systems and blood leak reduction are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.
Event or Problem Description
A medical worker reported that during hemodialysis (hd) treatment there was a blood leak (clot).In a follow up, it was verified that the clot (leak) occurred about 1 hour after starting the hd treatment.The reporter stated that after one hour of starting the treatment the alarm of arterial pressure, air, venous pressure and transmembrane pressure were activated.When the staff made an inspection it was detected that there were clots that caused the treatment to be stopped.Blood test strips were not used.The machine, a fresenius 4008s machine, alarmed appropriately with the alarm.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was 300 ml.There was no patient injury or medical intervention required as a result of this event.There was no visible damage to the dialyzer.The treatment was completed the same day with new supplies on the same machine.The device is not available to be returned to the manufacturer for evaluation.

• Brand Name: OPTIFLUX F18NRE 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
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; director, site quality; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 15538786
• Report Number: 0001713747-2022-00383
• Device Sequence Number: 11242376
• Product Code: FJI
• UDI-Device Identifier: 00840861100088
• UDI-Public: 00840861100088
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K162488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2022

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: 02/28/2025
• Device Model Number: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Device Catalogue Number: 0500318E
• Device Lot Number: 22BU07003
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 63 KG