MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

The alleged event was not confirmed by the manufacturing plant.The device was not returned to the plant for investigation.An investigation of the product history records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the product history review confirmed the labeling, material, and process controls were within specification.

Event Description

Dialysis clinic reported that when rinsing the blood back at the end of treatment a blood leak was observed in the dialyzer.The clinic tested the dialysate at the dialyzer and it tested positive for blood.The dialysis machine did not give a visual or audible alarm.Complainant does not know how long the blood leak was going on before they stopped the dialysate flow.Follow up with the dialysis clinic indicated that there was no medical intervention and the patient did not experience any complications.The dialysis machine was tested and passed all calibration test and remains in service.The dialyzer sample was discarded and the lot number and part number is unknown.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• 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: 7147701
• MDR Text Key: 95907265
• Report Number: 2937457-2017-01424
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2017

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
• Device Operator: Health Professional
• Device Model Number: 2008K
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2008
• 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