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 12/14/2022

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 registered nurse (rn) reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with registered nurse (rn) it was clarified that the blood leak occurred right at the start of the hd treatment.The blood leak was described as being an internal blood leak.The leak was visually observed in the dialysate lines/hansens.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was < 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed on a different machine with new supplies.The device is available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: a sample has not been provided for evaluation.The third party carrier's website was reviewed and it was verified that the provided 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 reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.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.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.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 registered nurse (rn) reported that a dialyzer blood leak occurred during a hemodialysis (hd) treatment.In a follow up with registered nurse (rn) it was clarified that the blood leak occurred right at the start of the hd treatment.The blood leak was described as being an internal blood leak.The leak was visually observed in the dialysate lines/hansens.The machine, a fresenius 2008t machine, alarmed appropriately with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was < 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed on a different machine with new supplies.The device is available 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: 16064356
• MDR Text Key: 307882258
• Report Number: 0001713747-2022-00640
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• 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: 22KU06013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2022
• 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 BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 64 KG