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 10/03/2022

Event Type  malfunction  

Event Description

A user facility nurse 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 was visually observed by the header cap near the hansen port.The machine, a fresenius 4008s 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 not provided when requested.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.

Manufacturer Narrative

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

Manufacturer Narrative

Plant investigation: the complaint device was not returned for manufacturer evaluation.An 11-second video was provided showing a dialyzer connected to the machine and blood is leaking from a fiber fragment near the hansen port.No other damage or irregularities were noted.The probable causes for this failure 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.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 one approved temporary deviation notice (dn) reported on the lot which was unrelated to the complaint event.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.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 nurse 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 was visually observed by the header cap near the hansen port.The machine, a fresenius 4008s 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 not provided when requested.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.The complaint device was reported to be unavailable to be returned to the manufacturer for evaluation.

• 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: 15681602
• MDR Text Key: 303179996
• Report Number: 0001713747-2022-00462
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100149
• UDI-Public: 00840861100149
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K162488
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22DU06029
• 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: 04/28/2022
• 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 4008S MACHINE; FRESENIUS 4008S MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 65 KG