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 10/14/2022

Event Type  malfunction  

Event Description

A user facility registered nurse (rn) reported a dialyzer blood leak occurred from a dialyzer during hemodialysis (hd) treatment.The dialyzer was reported to be available to be returned for manufacturer evaluation.Additional information was requested but was not received to date.

Manufacturer Narrative

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

Event Description

A user facility registered nurse (rn) reported a dialyzer blood leak occurred from a dialyzer during hemodialysis (hd) treatment.The dialyzer was reported to be available to be returned for manufacturer evaluation.Additional information was requested but was not received to date.

Manufacturer Narrative

Additional information: h10 plant investigation plant investigation: there were two photographs provided.The first photograph shows two dialyzers placed next to each other.The dialyzer (in full view) had a yellow sticky noted attached to it which states, "dialyzer - blood leak 10/14/2022 for investigation" (addressed in the current file) and the other dialyzer is barely visible in the photograph (addressed in another file).Both dialyzers appear to have blood within the dialyzer, on the outside of the fibers.The second photograph shows the dialyzer label, and there is visible blood pooled within the bell housing.There was no visible damage noted on the dialyzer.During the lot history review it was noted that there were two other complaints reported against the lot.Both are from the same complainant as the current file; one addresses the no-sample investigation for the current event and the other was opened to address the provided photographs depicting an internal dialyzer blood leak.A review of the production record was performed.There was no indication of product non-acceptance or deviation in the manufacturing process related to the complaint event.This includes non-conformances, rework, labeling, process controls, and any other occurrence in production that was potentially related to the complaint.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed 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.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 registered nurse (rn) reported a dialyzer blood leak occurred from a dialyzer during hemodialysis (hd) treatment.The dialyzer was reported to be available to be returned for manufacturer evaluation.Additional information was requested but was not received to date.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned to date for manufacturer evaluation.A lot history review was performed.There were no other complaints of any kind reported against the lot.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 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 2018-0161 (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: 15638774
• MDR Text Key: 306942737
• Report Number: 0001713747-2022-00438
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• 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: 22KU02001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2022
• 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
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES