MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500316E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/19/2022

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 materials manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with the hemodialysis (hd) technician it was clarified that the blood leak occurred 30 minutes into the hd treatment.The blood leak was described as being an external blood leak that was visually seen as blood was dripping from an area where the hansen meets the cylinder of the dialyzer.Blood tests strips were used and tested positive for the presence of blood.The machine was a fresenius 2008k2 machine.The machine did not alarm.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was able to complete treatment on a different machine with new supplies.The device is available to be returned to the manufacturer for evaluation.

Event Description

A materials manager reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with the hemodialysis (hd) technician it was clarified that the blood leak occurred within the first 30 minutes of hd treatment.The blood leak was described as being an external blood leak that was visually seen as blood was dripping from an area where the hansen meets the cylinder of the dialyzer.Blood tests strips were used and tested positive for the presence of blood.The machine was a fresenius 2008k2 machine.The machine did not alarm.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was 250 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was able to complete treatment on a different machine with new supplies.The device is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Additional information: d.9.,g.1.,h.3.Product investigation: a sample has not been provided for evaluation.The third party carrier's website was reviewed and it was verified that the shipping materials were sent to the customer and were subsequently received.In the event a sample is returned for evaluation, the complaint file will be updated.The report could not be confirmed as a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A review of the production record was performed.The production record review showed there was one approved temporary deviation notice in the production of this lot.It is unrelated to the reported complaint event.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.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 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: 14210655
• MDR Text Key: 290097230
• Report Number: 0001713747-2022-00141
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 21NU06011
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2021
• 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 2008K2; FRESENIUS 2008K2
• Patient Sex: Female