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

Catalog Number 0500316E

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2023

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 clinical manager (cm) reported that an internal dialyzer blood leak occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.Blood was confirmed to be visually observed in the dialysate compartment of the device.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood test strip was used to verify the presence of blood in the dialysate, and it tested positive.No physical damage was noticed on the dialyzer.Following the event, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 200 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was confirmed to be available for manufacturer evaluation.

Event Description

A user facility clinical manager (cm) reported that an internal dialyzer blood leak occurred immediately at the start of a patient¿s hemodialysis (hd) treatment.Blood was confirmed to be visually observed in the dialysate compartment of the device.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.A blood test strip was used to verify the presence of blood in the dialysate, and it tested positive.No physical damage was noticed on the dialyzer.Following the event, the treatment was paused.The patient¿s blood was not returned; estimated blood loss (ebl) was 200 ml.The cm confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was confirmed to be available for manufacturer evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no sample has been received.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 multiple approved temporary deviation notices (dns) reported on the lot which were 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.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.

• 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: 18420910
• MDR Text Key: 331711325
• Report Number: 0001713747-2023-00900
• Device Sequence Number: 1
• Product Code: KDI
• 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: 02/16/2024

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 Catalogue Number: 0500316E
• Device Lot Number: 23NU06032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2023
• 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: 39 YR
• Patient Sex: Male
• Patient Weight: 94 KG