MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 05/16/2022

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 nurse reported that a dialyzer blood leak occurred approximately 10 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed near the header cap.The machine, a fresenius 4008s 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 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d9, g1, h3 plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.However a photograph of the reported dialyzer was provided.The photograph shows a dialyzer connected to an hd machine.There is blood visible within the fibers, as expected during treatment.There is also visible blood outside of the fiber bundle within the bell housing of the dialyzer.This presence of blood outside of the fibers is indicative of an internal blood leak.The cause/source of the leak is not conclusively visible in the photograph.A batch records review was conducted by the manufacturer for the reported lot.There was one approved temporary deviation notice (dn), and one non-conformance (nc) in the production of this lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be 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 nurse reported that a dialyzer blood leak occurred approximately 10 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed near the header cap.The machine, a fresenius 4008s 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 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on the machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.

• Brand Name: OPTIFLUX 160NRE 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: 14461212
• MDR Text Key: 300334149
• Report Number: 0001713747-2022-00170
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

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: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 21PU06009
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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 4008S MACHINE; FRESENIUS 4008S MACHINE
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 58 KG