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 06/08/2022

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 clinic manager reported that a dialyzer blood leak occurred due to dialyzer fibers rupturing during a hemodialysis (hd) treatment.In a follow up with the clinic manager, it was clarified that the blood leak occurred immediately during first minute of initiation of hd treatment.The blood leak was described as being an internal blood leak that was visually seen as blood was pooling outside of the fibers on the venous end of the dialyzer and draining out the venous hansen.Blood tests strips were not used.The machine was a fresenius 2008t machine that did alarm appropriately with the blook leak alarm.Fresenius bloodlines were being used.There was no damage noted on the dialyzer prior to use.The patient¿s estimated blood loss (ebl) was approximately 100 - 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed on another machine with new supplies.The device is not available to be returned to the manufacturer for evaluation due to it was mistakenly put into a bio bin for disposal.

Event Description

A clinic manager reported that a dialyzer blood leak occurred due to dialyzer fibers rupturing during a hemodialysis (hd) treatment.In a follow up with the clinic manager, it was clarified that the blood leak occurred immediately during first minute of initiation of hd treatment.The blood leak was described as being an internal blood leak that was visually seen as blood was pooling outside of the fibers on the venous end of the dialyzer and draining out the venous hansen.Blood tests strips were not used.The machine was a fresenius 2008t machine that did alarm appropriately with the blood leak alarm.Fresenius bloodlines were being used.There was no damage noted on the dialyzer prior to use.The patient¿s estimated blood loss (ebl) was approximately 100 - 300 ml.There was no patient injury, adverse events, or medical intervention required as a result of this event.The treatment was completed on another machine with new supplies.The device is not available to be returned to the manufacturer for evaluation due to it was mistakenly put into a bio bin for disposal.

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation a review of the production record was performed.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 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: 14749692
• MDR Text Key: 303064708
• Report Number: 0001713747-2022-00207
• 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
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• 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: 22DU02020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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 2008 T MACHINE; FRESENIUS 2008 T MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 80 KG