MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500316E

Device Problem Fluid Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

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 clinical manager reported that a dialyzer blood leak occurred 15 minutes after the initiation of the patient¿s hemodialysis (hd) treatment. The blood leak was noted as being an external blood leak. The leak was visually observed. The patient¿s estimated blood loss (ebl) was approximately 250ml. There was no patient injury, adverse events, 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 returned to the manufacturer for analysis.

• 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; 475 west 13th street; ogden UT 84404
• Manufacturer (Section G): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 8160894
• MDR Text Key: 130331040
• Report Number: 1713747-2018-00487
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 0500316E
• Device Lot Number: 18HU06020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial