MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

There is a temporal relationship between the 2008 t machine encountering heparin pump alarms during the last 30 minutes of hd treatment and a blood clot in the venous blood line resulting in reported blood loss of 10 ml (exact amount unknown) warranting further er evaluation (course unknown).It was reported the nurse manually administered heparin (unknown dose).However, it is unknown if the pt.Received the entire prescribed dose of heparin during hd treatment the biomed technician reported the 2008t machine required replacement of the heparin pump and cable, actuator test board and cable, and function board.Based on the lack of available information, it cannot be determined what may have caused the heparin pump to alarm or to what degree the heparin alarm was related to blot clot formation in the venous blood line with in the extracorporeal circuit.The alleged event was not confirmed by the plant.The complaint sample 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

A hemodialysis clinic biomed engineer reported that the heparin pump on the 2008t machine jolted during initiation of bolus infusion of heparin.Additionally, it was reported during the last 30 minutes of this patient¿s (pt¿s) hemodialysis (hd) treatment the 2008t machine encountered heparin pump alarms (unknown number of times).As a result, the pt.Received injection of heparin manually (unknown amount) by the pt¿s nurse.The pt.Completed their hd treatment, but the pt.Was not reinfused their blood due to a visible blood clot in the venous blood line with in the extracorporeal circuit.The pt¿s blood loss was reported as approximately 10 milliliter (ml).It is unknown how the estimated blood loss was determined as the extracorporeal circuit typically holds between 250-300 ml of blood.Subsequently, the pt.Was sent to the emergency room (er) as a precaution.It is unknown if/what treatment was rendered in the er.The pt.Did not warrant hospital admission and the pt.Was able to resume hd treatment the following day.The biomed technician reported the 2008t machine required replacement of the heparin pump and cable, actuator test board and cable, and function board (unknown time in relation to pt.Event).Additional information was solicited.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 7139284
• MDR Text Key: 95801205
• Report Number: 2937457-2017-01392
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008T
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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