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 Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 03/14/2024

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 utilizing the optiflux 160nre dialyzer and the patient event of blood loss with subsequent blood transfusion following a reported dialyzer blood leak.The dialyzer was discarded and cannot be returned for manufacturer evaluation; however, photographs were submitted for review.The patient did not exhibit any signs or symptoms after the blood loss associated with the reported blood leak.However, the nephrologist noted a drop in the patient¿s hemoglobin values and ordered a blood transfusion for the patient.It is unknown when the initial hemoglobin values were obtained as no lab values and dates were provided.It is unknown if the initial hemoglobin values were on the date of the hd treatment or prior to 14/mar/2024.It is also unknown if the outset tablo hd machine provides the hemoglobin values during the treatment.Nevertheless, anemia in hd patients is extremely common and any blood loss in hd patients can cause a decrease in hemoglobin levels which requires treatment.Based on the available information, it is likely that the optiflux 160nre dialyzer blood leak caused or contributed to the patient¿s reported drop in hemoglobin and requirement for a blood transfusion.

Event Description

A hemodialysis (hd) user facility reported through a fresenius regional sales manager that an optiflux 160nre dialyzer cracked and contaminated the hd machine.In the initial reporting, a photo of the dialyzer was provided for review.Additional information was obtained through follow-up with the nurse manager (nm).A patient was initiated on hd treatment utilizing an outset tablo hd system and a fresenius optiflux 160nre dialyzer.Less than a few minutes into the patient¿s treatment, the tablo device alarmed with a blood leak alert.The dialyzer blood leak was internal, and blood was visually observed in the dialysate compartment of the dialyzer.A blood leak test strip was not used.The nm stated the blood leak was evident and use of a test strip was not necessary.Despite the initial report stating the dialyzer was cracked, the nm reported that there was no physical damage noticed on the dialyzer.A tablo cartridge and tubing system was also being used for the treatment.The patient¿s blood was not returned; their estimated blood loss (ebl) was 350-500ml.The patient did not exhibit any symptoms due to the blood loss and completed the hd treatment after being re-setup with new supplies on a different machine.After the treatment, it was noted that the patient¿s hemoglobin dropped a full point following the blood loss event.No lab values were provided.The nephrologist ordered the patient to undergo a blood transfusion (volume not provided) which occurred the following day.No further medical intervention was required.The patient is continuing hd treatments without further issue.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.

Event Description

A hemodialysis (hd) user facility reported through a fresenius regional sales manager that an optiflux 160nre dialyzer cracked and contaminated the hd machine.In the initial reporting, a photo of the dialyzer was provided for review.Additional information was obtained through follow-up with the nurse manager (nm).A patient was initiated on hd treatment utilizing an outset tablo hd system and a fresenius optiflux 160nre dialyzer.Less than a few minutes into the patient¿s treatment, the tablo device alarmed with a blood leak alert.The dialyzer blood leak was internal, and blood was visually observed in the dialysate compartment of the dialyzer.A blood leak test strip was not used.The nm stated the blood leak was evident and use of a test strip was not necessary.Despite the initial report stating the dialyzer was cracked, the nm reported that there was no physical damage noticed on the dialyzer.A tablo cartridge and tubing system was also being used for the treatment.The patient¿s blood was not returned; their estimated blood loss (ebl) was 350-500ml.The patient did not exhibit any symptoms due to the blood loss and completed the hd treatment after being re-setup with new supplies on a different machine.After the treatment, it was noted that the patient¿s hemoglobin dropped a full point following the blood loss event.No lab values were provided.The nephrologist ordered the patient to undergo a blood transfusion (volume not provided) which occurred the following day.No further medical intervention was required.The patient is continuing hd treatments without further issue.The dialyzer was not available to be returned for evaluation as it was reportedly discarded.

Manufacturer Narrative

Plant investigation: the complaint device was not returned for manufacturer evaluation.However, a photo of the dialyzer was provided for review.The photo shows the product label of the dialyzer.On one half of the dialyzer, there appears to be blood present within the dialyzer housing on the outside of the fibers; this is indicative of an internal leak.There was no visible damage noted on the dialyzer that may have contributed to the leak.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.The leak was able to be confirmed based on the provided photograph; however, the cause of the leak could not be determined from the media and the actual sample was not returned for testing.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: 19042610
• MDR Text Key: 339432012
• Report Number: 0001713747-2024-00275
• 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: Non-Healthcare Professional
• 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: 0500316E
• Device Lot Number: 24AU06010
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/26/2024
• Supplement Dates FDA Received: 05/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2024
• 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
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 135 KG