MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The facility staff observed blood in the drains and noted that the whole dialyzer filled with blood.The blood leak was noted as being an internal blood leak that could be visually observed by the facility staff.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information d9 and h3.Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.During the lot history review it was noted that there were three other complaints reported against the lot.A review of the production record was performed.There was one non-conformance (nc) and associated rework noted on the lot.There was no other 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 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.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 Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The facility staff observed blood in the drains and noted that the whole dialyzer filled with blood.The blood leak was noted as being an internal blood leak that could be visually observed by the facility staff.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 250 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

• Brand Name: OPTIFLUX 180NRE DIALYZER FINISHED ASSY.
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 16456726
• MDR Text Key: 310408116
• Report Number: 0001713747-2023-00150
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100156
• UDI-Public: 00840861100156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22LU05001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 03/25/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 94 KG