MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fatigue (1849); Hemorrhage/Bleeding (1888); Muscle Weakness (1967)

Event Date 08/26/2023

Event Type  malfunction  

Event Description

A user facility area technical operations manager (atom) reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained from the clinic manager (cm).The reported issue occurred approximately one hour after treatment initiation.The blood leak was noted as being an internal blood leak.The staff visually observed blood within the drain.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.The patient reported feeling weak following the reported event which the cm attributed to the blood loss that occurred as result of the blood leak.However there was no patient injury or medical intervention required as a result of this event.The patient reported feeling better the following day.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility area technical operations manager (atom) reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained from the clinic manager (cm).The reported issue occurred approximately one hour after treatment initiation.The blood leak was noted as being an internal blood leak.The staff visually observed blood within the drain.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.The patient reported feeling weak following the reported event which the cm attributed to the blood loss that occurred as result of the blood leak.However there was no patient injury or medical intervention required as a result of this event.The patient reported feeling better the following day.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d9, h3, h6 (device component code) plant investigation: a dialyzer from the reported lot was returned for evaluation.During gross visual examination, a potted fiber fragment was observed at approximately 150°, with the ports at 0°, on the non-cavity id end.Under magnification of 20x, the fiber fragment was found to be flush with the pu surface.An opposing end was not identified.There was no other damage or irregularities noted on the returned sample.The reported issue is confirmed.The probable causes for this failure 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 nonconformance reported on the lot which was 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.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.

Manufacturer Narrative

Correction: d9 (returned to manufacturer date), h6 (clinical code).

Event Description

A user facility area technical operations manager (atom) reported that a dialyzer blood leak occurred during the patient¿s hemodialysis (hd) treatment.Additional information was obtained from the clinic manager (cm).The reported issue occurred approximately one hour after treatment initiation.The blood leak was noted as being an internal blood leak.The staff visually observed blood within the drain.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient was restarted on a new machine and treatment completed successfully with new supplies.The patient reported feeling weak following the reported event which the cm attributed to the blood loss that occurred as result of the blood leak.However there was no patient injury or medical intervention required as a result of this event.The patient reported feeling better the following day.The complaint device was reported to be 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: 17643459
• MDR Text Key: 322194832
• Report Number: 0001713747-2023-00585
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

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: 0500318E
• Device Lot Number: 23HU02018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 09/27/2023; 09/29/2023
• Supplement Dates FDA Received: 09/28/2023; 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2023
• 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 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 92 KG