MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500318E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A hemodialysis (hd) clinic reported to fresenius that a dialyzer blood leak occurred upon initiation of a patient¿s hemodialysis (hd) treatment.The clinical manager (cm) reported the optiflux 180nre dialyzer had broken fibers inside of the dialyzer.There was no patient harm or adverse event reported at intake.It was unknown if the patient¿s blood was returned.The estimated blood loss (ebl) was unknown.The patient completed their treatment after being re-setup with new supplies on a different machine.The dialyzer was available to be returned for manufacturer evaluation.Additional information was requested but was not received to date.

Event Description

A user facility reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed interally within the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 100 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be available to be returned for manufacturer evaluation.

Manufacturer Narrative

Additional information: a1, a2, a3, a4, b5, d10 concomitant products.

Manufacturer Narrative

Additional information: d9, h3 plant investigation: complaint device returned to manufacturer for physical evaluation.During gross visual examination of sample, no defects or irregularities visually observed on fiber bundle or any of the molded dialyzer components.Sample subjected to a laboratory bubble point leak test.Dialyzer failed; a steady stream of bubbles were coming from the cut surface at approximately 210° on the non-cavity id end, with the ports positioned at 0°.Upon extraction of fiber bundle, a fiber fragment was noted from same area as leak.Fiber fragment measured 3.75 inches from the potting surface, an opposing end could not be isolated.No other damage or irregularities visually noted on dialyzer.During lot history review there was one other complaint reported against lot.Complaint addresses an internal blood leak; complaint was confirmed with provided photos; however, since sample was not returned the cause of internal leak is not known.An investigation of the device history records (dhr) was conducted by the manufacturer.There was one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.No indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during manufacturing process which could be associated with reported event.Lot met all release criteria.Investigation confirmed reported event.There is no recall associated with this complaint.Continuous improvement is of the utmost importance to fresenius medical care as we strive to provide dialysis products of highest quality to our patients.Reports of leaking product are investigated both individually as complaints, as well as via nc/capa program, in order to assess and improve our products and processes.Capas 2018-0171 (vision systems) and 2018-0161 (blood leak reduction) are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.

Event Description

A user facility reported that an internal dialyzer blood leak occurred at the start of a patient¿s hemodialysis treatment.It was reported that the blood was observed interally within the dialyzer.The machine, a fresenius 2008t, alarmed appropriately with a blood leak alert.Blood leak test strips were used and tested positive for the presence of blood.No further damage and/or defects were noted.Fresenius bloodlines were being utilized for the treatment and the patient¿s blood was not returned.The estimated blood loss (ebl) was reportedly 100 ml.It was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient was able to complete treatment on a different machine after re-setting up supplies.The dialyzer was reported to be available to be returned for manufacturer evaluation.

• 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: 14959636
• MDR Text Key: 304510560
• Report Number: 0001713747-2022-00241
• 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,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 21SU01002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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; FRESENIUS BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 110 KG