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 05/03/2022

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 user facility clinical manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that was visually observed at the arterial hanson and drain lines.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Event Description

A user facility clinical manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that was visually observed at the arterial hanson and drain lines.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Event Description

A user facility clinical manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that was visually observed at the arterial hanson and drain lines.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used to test for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: a sample was returned from the reported lot number for evaluation.During the visual examination of the sample, a delamination was observed on the cavity id end of the dialyzer extending from approximately 310° to 40°, with the dialysate ports situated at 0°.No other damage or irregularities were noted on the returned sample.The cause of the leak is confirmed to be a delamination.The probable causes for a delamination include: how the dialyzers are loaded into the potting carrousel, potting ratios, and conditioning carrousel media issues.As there was a leak due to a delamination causing an inadequate seal between the pu and the housing the probable the cause code leakage/seal has been selected, and as the separation occurs during manufacturing the cause code manufacturing deficiency was also selected.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.The investigation into the complaint was able to confirm the reported event.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 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 ; 9043166958
• MDR Report Key: 14487574
• MDR Text Key: 300439560
• Report Number: 0001713747-2022-00172
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• 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: 22BU07012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 79 KG