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

Catalog Number 0500320E

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A user facility reported during pretreatment setup a hair particle was observed inside the dialyzer during pre-treatment setup.Additional follow-up confirmed there was no patient involvement and no injury occurred.No damage to the dialyzer was noted.(b)(6)stated the dialyzer was removed from the machine and was available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: the sample was not returned to date for investigation.A definitive conclusion regarding the incident cannot be reached without examination of the complaint sample.During the lot history review it was noted there are no other reported complaints against the lot.There was no indication of product non-acceptance or deviation in the manufacturing process potentially related to the complaint.This includes non-conformances, rework, labeling, process controls and any other occurrence in production.The reported lot number passed pyrogen testing, was within sterilization dosage parameters and passed all release criteria.

Event Description

A user facility reported during pretreatment setup a hair particle was observed inside the dialyzer during pre-treatment setup.Additional follow-up confirmed there was no patient involvement and no injury occurred.No damage to the dialyzer was noted.Francisco stated the dialyzer was removed from the machine and was available to be returned for evaluation.

Manufacturer Narrative

Plant investigation: the device was returned to the manufacturer for physical evaluation.During the gross visual examination of the returned sample a black strand-like particulate was observed which possessed similar visual characteristics of a hair on the potting cut surface, beneath the cavity id end screw flange.No other irregularities were noted.An investigation of the device manufacturing records was conducted by the manufacturer.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 investigation into the cause of the reported problem was able to confirm the failure mode.The complaint has been deemed confirmed.

Event Description

A user facility reported during pretreatment setup a hair particle was observed inside the dialyzer during pre-treatment setup.Additional follow-up confirmed there was no patient involvement and no injury occurred.No damage to the dialyzer was noted.Francisco stated the dialyzer was removed from the machine and was available to be returned for evaluation.

Manufacturer Narrative

Corrective data on follow up 2: event date (b)(6) 2017.Additional information: device returned: yes.

Event Description

A user facility reported during pretreatment setup a hair particle was observed inside the dialyzer during pre-treatment setup.Additional follow-up confirmed there was no patient involvement and no injury occurred.No damage to the dialyzer was noted.(b)(6) stated the dialyzer was removed from the machine and was available to be returned for evaluation.

• 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; 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: 7122632
• MDR Text Key: 95770452
• Report Number: 1713747-2017-00401
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100163
• UDI-Public: 00840861100163
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K002761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 0500320E
• Device Lot Number: 17LU04007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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