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 Hemorrhage/Bleeding (1888); Tachycardia (2095)

Event Date 10/13/2023

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 registered nurse (rn) reported to fresenius that a dialyzer leak occurred during a patient's hemodialysis (hd) treatment.Additional information was obtained during follow-up with the clinic manager (cm) and the patient's hemodialysis registered nurse (hdrn).The reported issue was discovered toward the end of the patient¿s treatment.Fluid was noted to have accumulated on the outside of the lower lid of the dialyzer and was dripping.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss was approximately 300 ml.The patient experienced tachycardia (approximated at 120 to 130 bpm) which was affirmed to be attributed to comorbidities unrelated to dialysis or the use of any fresenius product(s) or device(s).The patient was sent to the emergency department (ed) as a precaution despite being asymptomatic upon treatment completion.The patient was evaluated in the ed and released to home on the same day with no medical intervention or hospital admission.It was confirmed the patient did not experience a serious injury or adverse event requiring medical intervention as a result of the external blood leak.The patient continues hd therapy on an in-center basis without incident following this event.The dialyzer is available to be returned to the manufacturer for physical evaluation.

Event Description

A user facility registered nurse (rn) reported to fresenius that a dialyzer leak occurred during a patient's hemodialysis (hd) treatment.Additional information was obtained during follow-up with the clinic manager (cm) and the patient's hemodialysis registered nurse (hdrn).The reported issue was discovered toward the end of the patient¿s treatment.Fluid was noted to have accumulated on the outside of the lower lid of the dialyzer and was dripping.There was no defect or damage seen on the dialyzer.The patient¿s estimated blood loss was approximately 300 ml.The patient experienced tachycardia (approximated at 120 to 130 bpm) which was affirmed to be attributed to comorbidities unrelated to dialysis or the use of any fresenius product(s) or device(s).The patient was sent to the emergency department (ed) as a precaution despite being asymptomatic upon treatment completion.The patient was evaluated in the ed and released to home on the same day with no medical intervention or hospital admission.It was confirmed the patient did not experience a serious injury or adverse event requiring medical intervention as a result of the external blood leak.The patient continues hd therapy on an in-center basis without incident following this event.The dialyzer is available to be returned to the manufacturer for physical evaluation.

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 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 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: 17995661
• MDR Text Key: 326379550
• Report Number: 0001713747-2023-00730
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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: 23BU02008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/16/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 86 KG