MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 200NRE DIALYZER FINISHED ASSY. DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 0500320E

Device Problem Fluid Leak (1250)

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

Event Date 12/23/2020

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 registered nurse (rn) reported that an external dialyzer blood leak occurred during a patient¿s hemodialysis (hd) treatment. Approximately five minutes into the treatment, blood was observed leaking from the bottom of the dialyzer. The leak was described as a small drip. The machine did not alarm. The patient was dialyzing on a fresenius 2008t machine and was utilizing fresenius bloodlines. No visible damage was identified on the dialyzer, and according the rn, the device was not dropped. After the blood leak was identified, the patient¿s treatment was paused. The patient¿s blood was not returned; estimated blood loss (ebl) was 300 ml. The rn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event. The patient completed their treatment after being re-setup with new supplies on a different machine. The dialyzer was not available to be returned for evaluation; the device was reportedly discarded.

• Brand Name: OPTIFLUX 200NRE 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11090884
• MDR Text Key: 224305260
• Report Number: 1713747-2020-00533
• 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: 01/27/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0500320E
• Device Catalogue Number: 0500320E
• Device Lot Number: 20LU04011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial