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 Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility nurse manager reported that a dialyzer blood leak occurred immediately after the initiation of the patient¿s hemodialysis (hd) treatment. 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 as the leak could be visually observed within the dialyzer. The nurse stated that the leak was internal. There was no defect or damage seen on the dialyzer. The patient¿s estimated blood loss (ebl) was approximately 150 ml. There was no patient injury, adverse events, or medical intervention required as a result of this event. The nurse manager noted that saline was administered to replace the blood loss per standing order. The patient was then 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 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: 14396785
• MDR Text Key: 292220147
• Report Number: 0001713747-2022-00159
• Device Sequence Number: 1
• Product Code: KDI
• 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

Reporter Occupation

• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0500316E
• Device Catalogue Number: 0500316E
• Device Lot Number: 22CU06003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 05/13/2022 Patient Sequence Number: 1

Treatment

FRESENIUS 2008K2 MACHINE; FRESENIUS 2008K2 MACHINE; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES