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 Problems Respiratory Arrest (4461); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

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 at the end of a patient¿s hemodialysis (hd) treatment.In a follow up, the rn clarified that the blood leak occurred at the end of hd treatment while starting to rinse patient back.The treatment was immediately stopped and checked with blood strips which did test positive.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm a few minutes earlier, but because the leak was not visually seen and blood test strips indicated negative at that time, the treatment was continued until the leak then became visible at the top of the dialyzer and into the hansen tubing.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was the amount in venous tubing (no estimated amount provided).There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage seen on the dialyzer prior to treatment.The treatment was considered completed at the time of the event.The device is available to be returned to the manufacturer for evaluation.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred at the end of a patient¿s hemodialysis (hd) treatment.In a follow up, the rn clarified that the blood leak occurred at the end of hd treatment while starting to rinse patient back.The treatment was immediately stopped and checked with blood strips which did test positive.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm a few minutes earlier, but because the leak was not visually seen and blood test strips indicated negative at that time, the treatment was continued until the leak then became visible at the top of the dialyzer and into the hansen tubing.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was the amount in venous tubing (no estimated amount provided).There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage seen on the dialyzer prior to treatment.The treatment was considered completed at the time of the event.The device is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d.9.,h.3.Plant investigation: the complaint device was not returned to the manufacturer for physical evaluation.The third party carrier's website was reviewed and it was verified that the fmcna-provided shipping materials were sent to the customer and were subsequently received.In the event a sample is returned for evaluation, the complaint file will be updated.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached based on the information provided.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.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 at the end of a patient¿s hemodialysis (hd) treatment.In a follow up, the rn clarified that the blood leak occurred at the end of hd treatment while starting to rinse patient back.The treatment was immediately stopped and checked with blood strips which did test positive.The blood leak was described as being an internal blood leak.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm a few minutes earlier, but because the leak was not visually seen and blood test strips indicated negative at that time, the treatment was continued until the leak then became visible at the top of the dialyzer and into the hansen tubing.Fresenius bloodlines were used.The patient¿s estimated blood loss (ebl) was the amount in venous tubing (no estimated amount provided).There was no patient injury, adverse events or medical intervention required as a result of this event.There was no visible damage seen on the dialyzer prior to treatment.The treatment was considered completed at the time of the event.The device is 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: 15185520
• MDR Text Key: 301154942
• Report Number: 0001713747-2022-00302
• 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,Followup
• Report Date: 09/19/2022

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
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22EU03020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/08/2022
• Supplement Dates Manufacturer Received: 08/24/2022; 09/06/2022
• Supplement Dates FDA Received: 08/29/2022; 09/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 100 KG