MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT OPTIFLUX 180NRE DIALYZER FINISHED ASSY.; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 0500318E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: although it was stated by the user facility that the complaint sample is available to be returned to the manufacturer, no sample has been received for evaluation at this time.A production records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.The lot had two approved temporary deviation notices (dn) that were unrelated to the reported complaint event.There was no indication of product non-acceptance or deviation during the manufacturing process which could be associated with the reported event.The review included a check of non-conformances, rework, labeling, process controls, and any other occurrence in production potentially related to the complaint.The lot passed all release criteria.The reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

A user facility patient care technician (pct) reported that an internal dialyzer blood leak occurred immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The machine alarmed for blood leak, but blood was not visually observed.However, blood test strips were used at the drain line and confirmed the presences of blood in the dialysate.No dialyzer defect or damage was visible.The patient¿s estimated blood loss (ebl) was noted as being approximately 200ml as the patient¿s blood was not returned in the circuit.No patient adverse effects were experienced and no medical intervention was required as a result of this event.The patient completed treatment with a new set-up of supplies on the same machine.The complaint device was reported to be available to be returned to the manufacturer for evaluation.

• 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; 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: 7112315
• MDR Text Key: 95072613
• Report Number: 1713747-2017-00398
• 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: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 0500318E
• Device Lot Number: 17KU03015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2017
• 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
• Patient Age: 93 YR
• Patient Weight: 64