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 10/10/2022

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 registered nurse (rn) reported that a dialyzer blood leak occurred approximately 60 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed by the clinic staff as the dialysate within the dialyzer was tinged pink.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury 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 dialyzer from the reported lot was returned for evaluation.During gross visual examination, a potted fiber fragment, measuring approximately 8.98mm in length, was observed at approximately 270°, with the dialysate ports situated at 0°, on the cavity id end.There was no other damage or irregularities noted on the returned sample.The reported issue has been confirmed.The probable causes for this failure to occur are related to the handling of the fiber bundle during production and during the insertion process of the fiber bundle into the dialyzer housing.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 user facility registered nurse (rn) reported that a dialyzer blood leak occurred approximately 60 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed by the clinic staff as the dialysate within the dialyzer was tinged pink.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury 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: 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 sample has been received by the manufacturer and is currently under evaluation.A supplemental mdr will be submitted upon completion of this activity. .

Event Description

A user facility registered nurse (rn) reported that a dialyzer blood leak occurred approximately 60 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak that could be visually observed by the clinic staff as the dialysate within the dialyzer was tinged pink.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury 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.

• 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: 15683603
• MDR Text Key: 306998753
• Report Number: 0001713747-2022-00463
• 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: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2022
• 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: 22KU02018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 59 KG