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 Problems Hemorrhage/Bleeding (1888); Vomiting (2144); Chills (2191)

Event Date 12/23/2023

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal and likely causal relationship between hemodialysis treatment utilizing the optiflux 160nre dialyzer and the event of a blood leak with subsequent patient diagnosis of bacteremia preceded by reports of chills and vomiting.The optiflux 160nre dialyzer reportedly had a leak during treatment on (b)(6) 2023.The leak was indicated by the machine alarm within two minutes of treatment initiation which resulted in the stopping of the treatment.The patient¿s blood was not returned due to the leak and the treatment was re-set up with new supplies and subsequently completed which minimized the patient¿s exposure to contamination.However, the treatment was done on the same 2008t machine that the blood leak occurred.The 2008t machine operator¿s manual states that after a dialyzer blood leak occurs, the machine should be disinfected prior to the next treatment.It is unknown if the clinic disinfected the machine after the blood leak occurred.This could have potentially exposed the patient to contamination resulting in the bacteremia diagnosis.Based on the available information, it is likely that the optiflux 160nre dialyzer blood leak caused or contributed to the patient¿s reported bacteremia event.

Event Description

A user facility charge nurse (cn) reported to fresenius that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred within the first two minutes of treatment.Blood was reported to be visually observed on the arterial side of the dialyzer, outside of the fibers.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.The dialysate was tested with blood test strips and tested positive for blood.No physical damage was noted on the dialyzer.Following the event, the treatment was stopped.The patient¿s blood was not returned; their estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on the same machine and completed their treatment without further issue.Following the treatment, the patient reported chills and vomiting.Blood cultures were taken, and the results came back positive for bacteremia.This post-treatment timeline of events was clarified upon follow-up with the cn.The patient was sent home after the treatment.The patient developed chills and began vomiting later that day.The patient reportedly went to the emergency room (er) where blood cultures were obtained.The patient was then sent home.The blood cultures came back positive for bacteremia (no organism or species provided) and the patient was called back to the hospital to be initiated on antibiotic therapy.The patient was administered the first dose of antibiotics (drug, route, and dose unknown).There was no indication that the patient was admitted to the hospital.The patient received 7 additional doses of antibiotics via intravenous push (ivp) during their regularly scheduled hd treatments.The patient has recovered and continues to complete hd therapy.The dialyzer that was in use when the blood leak occurred was reported to be available for manufacturer evaluation.

Event Description

A user facility charge nurse (cn) reported to fresenius that an internal dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment.The blood leak occurred within the first two minutes of treatment.Blood was reported to be visually observed on the arterial side of the dialyzer, outside of the fibers.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.The dialysate was tested with blood test strips and tested positive for blood.No physical damage was noted on the dialyzer.Following the event, the treatment was stopped.The patient¿s blood was not returned; their estimated blood loss (ebl) was 300 ml.The patient was re-setup with new supplies on the same machine and completed their treatment without further issue.Following the treatment, the patient reported chills and vomiting.Blood cultures were taken, and the results came back positive for bacteremia.This post-treatment timeline of events was clarified upon follow-up with the cn.The patient was sent home after the treatment.The patient developed chills and began vomiting later that day.The patient reportedly went to the emergency room (er) where blood cultures were obtained.The patient was then sent home.The blood cultures came back positive for bacteremia (no organism or species provided) and the patient was called back to the hospital to be initiated on antibiotic therapy.The patient was administered the first dose of antibiotics (drug, route, and dose unknown).There was no indication that the patient was admitted to the hospital.The patient received 7 additional doses of antibiotics via intravenous push (ivp) during their regularly scheduled hd treatments.The patient has recovered and continues to complete hd therapy.The dialyzer that was in use when the blood leak occurred was reported to be available for manufacturer evaluation.

Manufacturer Narrative

Additional information: h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.Blood was present throughout the dialyzer.The corporate provided blood port and adapter caps were attached to the returned device.The dialyzer was subjected to a bubble point leak test.A leak was detected at approximately 175° on the non-cavity id end, with the dialysate ports situated at 0°.The dialyzer was then subjected to destructive disassembly for further visual examination.Upon extraction of the fiber bundle, a potted fiber fragment measuring approximately 0.05 mm in length above the polyurethane (pu) was identified at the leak location on the non-cavity id end.An opposing end was not identified.Further examination of the complaint device did not identify any other damage or irregularities.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) and a non-conformance (nc) in the production of this lot.They were all 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 was able to confirm 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: 18610999
• MDR Text Key: 334141238
• Report Number: 0001713747-2024-00058
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0500316E
• Device Lot Number: 23LU06021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 62 KG