MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN- FMC PRODUCT; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number UNKNOWN-FMCPRODUCT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 10/27/2007

Event Type  Death  

Manufacturer Narrative

Plant investigation: the actual device was not returned to the manufacturer for physical evaluation.Further investigation was not able to be performed.The serial number of the cycler used was unknown, therefore an investigation of the device manufacturing records was unable to be conducted by the manufacturer.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This is a report of a hemodialysis patient who expired.A written response to software upgrade letter was received and indicated that the patient passed away.No further information is available at this time.Should additional information become available, the file will be reassessed and updated accordingly.

• Brand Name: UNKNOWN- FMC PRODUCT
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7506062
• MDR Text Key: 107962595
• Report Number: 2937457-2018-01311
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN-FMCPRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death