MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500320E

Device Problems Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user clinic.Additional details were provided upon follow-up with the outpatient clinic¿s facility administrator (fa).The fa was surprised that the event was reported as a dialyzer blood leak.The fa didn¿t think that a true dialyzer blood leak occurred, nor did they think that there was anything wrong with the dialyzer.The fa reported that a patient experienced high venous pressure alarms towards the beginning of their hd treatment.The treatment was discontinued as it was determined the issue was with the dialysis needle at the patient¿s arteriovenous access.Clinic staff attempted to adjust the needle to continue with the hd treatment, but flow could not be resumed.The dialyzer was determined to be clotted at this point and, as clinic staff disconnected the patient to set them up with new supplies, the 2008t hd system alarmed with a blood leak alarm.No blood was visually observed in the dialysate.Per policy, a blood test strip was used, and it tested positive.It was confirmed there were no evident defects observed on the dialyzer.It was also confirmed there were no known issues or defects with the fresenius bloodlines being used.As a result of this event, there was an undetermined amount of blood loss.The patient was not able to complete their treatment on the day of the reported event as they were sent to the emergency department to have their arteriovenous access flushed for patency.The patient was admitted to the hospital where they underwent a procedure for a new arteriovenous catheter to be placed.The patient dialyzed at the hospital with the newly placed catheter, and they were discharged a day or two following admission (exact date unknown).The patient continues hd therapy on an in-center basis without incident post-discharge.The fa said the disposable devices that were used for the treatment had been discarded.

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical review: there was no report that the patient experienced a serious injury as a result of this event.Additionally, there was no indication this patient¿s occluded arteriovenous access, the resulting blood leak and the associated hospitalization were due to a deficiency or malfunction of any fresenius products or devices.Based on the available information, there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or device.

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 were multiple approved temporary deviation notices (dns) reported on the lot which were 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.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.

Event Description

A corporate inventory manager reported to fresenius that a dialyzer blood leak occurred at a hemodialysis (hd) user clinic.Additional details were provided upon follow-up with the outpatient clinic¿s facility administrator (fa).The fa was surprised that the event was reported as a dialyzer blood leak.The fa didn¿t think that a true dialyzer blood leak occurred, nor did they think that there was anything wrong with the dialyzer.The fa reported that a patient experienced high venous pressure alarms towards the beginning of their hd treatment.The treatment was discontinued as it was determined the issue was with the dialysis needle at the patient¿s arteriovenous access.Clinic staff attempted to adjust the needle to continue with the hd treatment, but flow could not be resumed.The dialyzer was determined to be clotted at this point and, as clinic staff disconnected the patient to set them up with new supplies, the 2008t hd system alarmed with a blood leak alarm.No blood was visually observed in the dialysate.Per policy, a blood test strip was used, and it tested positive.It was confirmed there were no evident defects observed on the dialyzer.It was also confirmed there were no known issues or defects with the fresenius bloodlines being used.As a result of this event, there was an undetermined amount of blood loss.The patient was not able to complete their treatment on the day of the reported event as they were sent to the emergency department to have their arteriovenous access flushed for patency.The patient was admitted to the hospital where they underwent a procedure for a new arteriovenous catheter to be placed.The patient dialyzed at the hospital with the newly placed catheter, and they were discharged a day or two following admission (exact date unknown).The patient continues hd therapy on an in-center basis without incident post-discharge.The fa said the disposable devices that were used for the treatment had been discarded.

• Brand Name: OPTIFLUX 200NRE 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: 19067216
• MDR Text Key: 340103436
• Report Number: 0001713747-2024-00285
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• 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: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/04/2024

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: 0500320E
• Device Lot Number: 23SU04016
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2023
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 114 KG