MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008K2

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

Patient Problems Death (1802); Loss of consciousness (2418); Blood Loss (2597); Hypervolemia (2664)

Event Date 10/20/2017

Event Type  Death  

Manufacturer Narrative

Device evaluation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.Clinical evaluation: a temporal association between the adverse event(s) of blood loss and eventual death and the 2008k2 machine exists.However the blood loss was the probable cause of loss of consciousness and subsequent death as a direct result of the patients¿ dialysis catheter becoming severed during the hemodialysis treatment.It is unknown what may have occurred to cause the catheter to become severed.The dialysis catheter (brand and type unknown) is not manufactured by fresenius medical care.Additionally, there is no documentation or allegation that the 2008k2 machine or any other fresenius product(s) malfunctioned or did not perform as expected.

Event Description

A medical professional reported that a hemodialysis patient bled out from a severed catheter during treatment at the clinic.The patient was able to be revived in the clinic, however, subsequently expired in the ambulance headed to the hospital.The dialysis machine displayed no diagnostic messages or audible alarms.

Manufacturer Narrative

Corrective data: (b)(6) 2018.End stage renal disease.

Event Description

A medical professional reported that a hemodialysis patient bled out from a severed catheter during treatment at the clinic.The patient was able to be revived in the clinic, however, subsequently expired in the ambulance headed to the hospital.The dialysis machine displayed no diagnostic messages or audible alarms.

Manufacturer Narrative

Corrective data: adverse event selected.

Event Description

A medical professional reported that a hemodialysis patient bled out from a severed catheter during treatment at the clinic.The patient was able to be revived in the clinic, however, subsequently expired in the ambulance headed to the hospital.The dialysis machine displayed no diagnostic messages or audible alarms.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 7188545
• MDR Text Key: 97269424
• Report Number: 2937457-2018-00166
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008K2
• Device Catalogue Number: 190610
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Event Location: Clinic - Walk In; Other
• Date Manufacturer Received: 04/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death