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 Thrombosis/Thrombus (4440)

Event Date 10/24/2022

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 clinic manager (cm) reported a hemodialysis (hd) treatment where a dialyzer blood leak occurred and a blood clot within a patient resulted in clotting within the fresenius optiflux dialyzer and bloodlines.The clotting was visibly apparent to the facility staff.The cm confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak, transmembrane pressure (tmp), and venous alarms.Blood test strips were used and tested positive for the presence of blood.The cm stated that the patient¿s treatment was paused and their blood was not returned.The patient¿s estimated blood loss (ebl) was approximately 240 ml.The staff attempted to re-setup treatment however the patient's access was clotting off.The patient underwent an ultrasound where a clot was identified in their arm.The patient was sent to the emergency room and admitted.The following day the patient underwent a procedure to have their access declotted and a hemocatheter (brand unknown) inserted.The patient is continuing hemodialysis with no further issues.The cm stated that the patient¿s blood clot was responsible for the clotting within the dialyzer and bloodlines.The cm fresenius supplies did not cause or contribute to the patient¿s blood clot.The cm stated that the dialyzer was available to be returned to the manufacturer for physical evaluation.A sample return shipping kit will be sent to the cm to obtain the sample for investigation.

Event Description

A user facility clinic manager (cm) reported a hemodialysis (hd) treatment where a dialyzer blood leak occurred and a blood clot within a patient resulted in clotting within the fresenius optiflux dialyzer and bloodlines.The clotting was visibly apparent to the facility staff.The cm confirmed that the machine, a fresenius 2008t machine, alarmed appropriately with blood leak, transmembrane pressure (tmp), and venous alarms.Blood test strips were used and tested positive for the presence of blood.The cm stated that the patient¿s treatment was paused and their blood was not returned.The patient¿s estimated blood loss (ebl) was approximately 240 ml.The staff attempted to re-setup treatment however the patient's access was clotting off.The patient underwent an ultrasound where a clot was identified in their arm.The patient was sent to the emergency room and admitted.The following day the patient underwent a procedure to have their access declotted and a hemocatheter (brand unknown) inserted.The patient is continuing hemodialysis with no further issues.The cm stated that the patient¿s blood clot was responsible for the clotting within the dialyzer and bloodlines.The cm fresenius supplies did not cause or contribute to the patient¿s blood clot.The cm stated that the dialyzer was available to be returned to the manufacturer for physical evaluation.A sample return shipping kit will be sent to the cm to obtain the sample for investigation.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: one dialyzer from the reported lot number was returned for evaluation.The sample was received with blood throughout the fibers and pooled in the bell housing area indicative of a leak.There was coagulated blood (indication of usage) within each of the header caps.The sample was subjected to a laboratory bubble point test and no leaks were detected, possibly due to coagulated blood.The sample was then disassembled, and there were no issues identified that may have contributed to the blood leak.As there was no irregularities visually observed on the dialyzer that may have contributed to the blood leak, it may be deduced that the leak was caused by a damaged fiber (fragment or broken).The probable causes for this failure to occur are related to the handling of the fiber bundle during production and during the insertion process of the fiber bundle into the dialyzer housing.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot 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.The investigation into the complaint confirmed the reported event.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: 15811270
• MDR Text Key: 307175827
• Report Number: 0001713747-2022-00538
• 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,Followup
• Report Date: 01/09/2023

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: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22KU06022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 12/30/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 73 KG