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 07/21/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A hemodialysis (hd) clinic operations manager reported to fresenius via email that a dialyzer was leaking.Attached to the email were photos that showed blood had leaked externally from the dialyzer.There was no indication that the blood leak resulted in an patient injury or harm, nor was there any report of required medical intervention.The patient's estimated blood loss (ebl) is not known.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

Manufacturer Narrative

Plant investigation: no sample was returned to the manufacturer for evaluation.A definitive conclusion regarding the complaint incident cannot be reached based on the information provided.However, four photos were provided.The first photo shows an up-close view of the dialyzer label.The second and fourth photos show an up-close view of the header cap and there appears to be blood present in the threads and pooled on the rim.The third photo shows blood on the floor.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.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.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.Vision systems and blood leak reduction capas are recent examples of leak related investigations directed at an overall reduction in dialyzer leaks.The leak was confirmed with the provided photos.Potential causes of header leaks include damage to the threads, cracked header caps, and polyurethane (pu) buildup on the threads causing torque not to be met, delamination, a pu sliver under the o-ring, or a damaged o-ring.The probable cause for this failure to occur could be rough handling (causing cracks or physical damage), and anomalies during the manufacturing process such as incorrect potting ratios or incorrect placement of a dialyzer in the carousel.Since it is unknown what type of leak may have occurred as no sample was provided, the probable cause could not be established.

Event Description

A hemodialysis (hd) clinic operations manager reported to fresenius via email that a dialyzer was leaking.Attached to the email were photos that showed blood had leaked externally from the dialyzer.There was no indication that the blood leak resulted in an patient injury or harm, nor was there any report of required medical intervention.The patient's estimated blood loss (ebl) is not known.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

• 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: 15626667
• MDR Text Key: 306616888
• Report Number: 0001713747-2022-00427
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500318E
• Device Catalogue Number: 0500318E
• Device Lot Number: 22EU03008
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2022
• 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