MAUDE Adverse Event Report: OGDEN MANUFACTURING PLANT F8 DIALYZER FINISHED ASSY (CASE); DIALYZER, CAPILLARY, HOLLOW FIBER

Catalog Number	0500164A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
Event or Problem Description
A user facility administrator reported experiencing problems with a dialyzer during hemodialysis treatment, and stated the membranes of the dialyzer were breaking upon use and that the filter was being rejected by the system due to pressure failure.Blood loss was also reported.Additional information was requested and was not received to date.
Additional Manufacturer Narrative
Plant investigation: a production records review was performed on the reported lot.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 reported complaint.The lot passed all release criteria.
Event or Problem Description
A user facility administrator reported experiencing problems with a dialyzer during hemodialysis treatment, and stated the membranes of the dialyzer were breaking upon use and that the filter was being rejected by the system due to pressure failure.Blood loss was also reported.Additional information was requested and was not received to date.
Additional Manufacturer Narrative
Plant investigation: a production records review was performed on the reported lot.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 reported complaint.The lot passed all release criteria.
Event or Problem Description
A user facility administrator reported experiencing problems with a dialyzer during hemodialysis treatment, and stated the membranes of the dialyzer were breaking upon use and that the filter was being rejected by the system due to pressure failure.Blood loss was also reported.Additional information was requested and was not received to date.

• Brand Name: F8 DIALYZER FINISHED ASSY (CASE)
• Common Device Name: DIALYZER, CAPILLARY, HOLLOW FIBER
• Manufacturer (Section D): OGDEN MANUFACTURING PLANT; 475 west 13th street; ogden UT 84404
• MDR Report Key: 7154605
• Report Number: 1713747-2017-00414
• Device Sequence Number: 16641328
• Product Code: FJI
• UDI-Device Identifier: 00840861100040
• UDI-Public: 00840861100040
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K870725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 0500164A
• Device Lot Number: 17AU04014
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 02/21/2018; 04/16/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 02/26/2018; 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1