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 Dyspnea (1816); Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908)

Event Date 03/15/2024

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.There is a temporal and possible causal relationship between hemodialysis treatment utilizing the optiflux 180nre dialyzer and patient event of blood loss with reported hypertension and shortness of breath with hospitalization.However, despite the patient¿s blood loss of approximately 150ml due to a reported dialyzer blood leak, the patient was documented as having symptoms of hypertension and shortness of breath prior to the start of the treatment as well as at the time of the blood loss event.No information was provided as to the patient¿s blood pressure values prior to the start of treatment and at the time of the blood loss event.It is unknown if the symptoms had resolved prior to the blood loss event and if the blood loss caused the symptoms to return.The common clinical findings to a blood loss event would be hypotension (low blood pressure) and not hypertension (high blood pressure) as reported in this case.Based on the limited information, it cannot be concluded if the blood loss from the reported dialyzer blood leak caused or contributed to the patient¿s reported hypertension and dyspnea with hospitalization as it was pre-existing prior to the initiation of the hd treatment.

Event Description

A user facility¿s facility administrator (fa) reported that a visible internal dialyzer blood leak occurred 40 minutes into a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient¿s estimated blood loss (ebl) was approximately 150 ml.The patient did experience an adverse event as a result of this event.The patient had hypertension and shortness of breath, but those symptoms were also present before the start of treatment.The patient was admitted to adiran health wakeforest baptist hosspital following this event.No additional information on the hospitalization is available.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Event Description

A user facility¿s facility administrator (fa) reported that a visible internal dialyzer blood leak occurred 40 minutes into a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t hemodialysis machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.There was no defect or damage noted on the dialyzer.Fresenius bloodlines were also in use.The patient¿s estimated blood loss (ebl) was approximately 150 ml.The patient did experience an adverse event as a result of this event.The patient had hypertension and shortness of breath, but those symptoms were also present before the start of treatment.The patient was admitted to (b)(6) hospital following this event.No additional information on the hospitalization is available.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: b7, d9, h3 plant investigation: plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the gross visual examination of the sample, a delamination in the polyurethane (pu) was noted on the non-cavity id end.The delamination extended from approximately 320° to 40°, with the ports at 0°.Further visual examination did not identify any other damage or irregularities on the returned sample.The dialyzer was not subjected to a laboratory leak test since this failure is known to impact the integrity of the dialyzer.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 notice (dn) 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.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: 2018-0171 (vision systems) and 1141369 (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: 18996054
• MDR Text Key: 338883745
• Report Number: 0001713747-2024-00239
• 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: 04/26/2024

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: 0500318E
• Device Lot Number: 24AU01015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/28/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2024
• 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 BLOODLINE.; FRESENIUS BLOODLINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 48 KG