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 12/05/2023

Event Type  malfunction  

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.There were four approved temporary deviation notices (dns) and one non-conformance (nc) reported on the lot which were unrelated to the complaint event.There was no indication of product nonacceptance, deviation, nc, 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.

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak during a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow up with the facility¿s clinical manager (cm).The cm described the details of the scenario as "unique".When the hd machine (a fresenius 2008t) was put into sequential mode at the beginning of treatment, it alarmed with a blood leak alarm.The staff tested the drain with a blood test strip, and it tested positive.The staff then turned sequential mode off and tested the drain again, and it tested negative.The alarm was cleared, and the patient¿s treatment was continued.After about two hours of treatment, the cm learned what had happened and advised the staff to use another blood test strip.This time the test strip was ¿faintly positive¿, and the cm told the staff that the treatment had to be stopped.The cm confirmed there was only one blood leak alarm, which occurred at the beginning of the treatment.The machine did not alarm again after that.Per the cm, the blood leak was not visually observed; it was not obvious that an internal blood leak had occurred.There were no defects noted on the dialyzer.The patient¿s blood was not returned; estimated blood loss (ebl) was 250 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 not available to be returned for evaluation as it was reportedly discarded.

• 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: 18422401
• MDR Text Key: 331678102
• Report Number: 0001713747-2023-00902
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• 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
• Report Date: 12/30/2023

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 Catalogue Number: 0500316E
• Device Lot Number: 23LU06019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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 BLOODLINES.
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 68 KG