MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT UNKNOWN- DIALYZER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- DIALYZER

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2022

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 facebook social media user reported that a dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.The social media user reported that blood was visibly leaking into the hansen line and then down the drain.Two photos were included in the initial reporting for reference.The label on the dialyzer is not visible in either photo; it is unknown what type of dialyzer was being used.It was reported that blood was found in the hansen line before a blood leak alarm went off, indicating that it was caught before blood reached the blood leak detector.The facility's biomedical technician instructed the social media user to pull the machine.No further details were provided.

Manufacturer Narrative

Plant investigation: the reported complaint was confirmed with the provided photographs.There were two photographs provided.The first photograph shows the drain to which the hansen lines run to with visible blood within the draining fluid from treatment.The second photo shows a dialyzer connected to a hemodialysis machine and there is visible blood outside the fibers, within the bell housing (pooled near the base).There is no damage or irregularities that are visible that may have contributed to the leak.The catalog and lot numbers were not provided.A shipping history search for dialyzers delivered to the account could not be performed because an account number was not identified.As such, device history and manufacturing reviews could not be conducted.The provided photographs indicate that a leak occurred, however, the cause cannot be determined.There was no obvious cause noted in the photographs and the actual sample product was not returned for evaluation.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 facebook social media user reported that a dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.The social media user reported that blood was visibly leaking into the hansen line and then down the drain.Two photos were included in the initial reporting for reference.The label on the dialyzer is not visible in either photo; it is unknown what type of dialyzer was being used.It was reported that blood was found in the hansen line before a blood leak alarm went off, indicating that it was caught before blood reached the blood leak detector.The facility's biomedical technician instructed the social media user to pull the machine.No further details were provided.

Event Description

A facebook social media user reported that a dialyzer blood leak occurred during a patient's hemodialysis (hd) treatment.The social media user reported that blood was visibly leaking into the hansen line and then down the drain.Two photos were included in the initial reporting for reference.The label on the dialyzer is not visible in either photo; it is unknown what type of dialyzer was being used.It was reported that blood was found in the hansen line before a blood leak alarm went off, indicating that it was caught before blood reached the blood leak detector.The facility's biomedical technician instructed the social media user to pull the machine.No further details were provided.

• Brand Name: UNKNOWN- DIALYZER
• 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: 15692512
• MDR Text Key: 306900076
• Report Number: 0001713747-2022-00466
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• 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,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN- DIALYZER
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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