MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

Device Problem Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2016

Event Type  malfunction  

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (biomed) at the user facility reported that the 2008t hemodialysis (hd) machine powered down unexpectedly while a patient underwent a routinely scheduled hd treatment.The patient was moved to another machine to continue the hd therapy, and the treatment was able to be successfully completed without any further issues.The clinic manager stated that the patient experienced a minimal amount of blood loss when the power down occurred.The patient's estimated blood loss (ebl) was noted as being approximately 50cc.No patient adverse effects were experienced and no medical intervention was required as a result of this event.Follow-up information provided by the clinic manager revealed that no alarm or system message was generated when the issue occurred.The staff noticed that the machine¿s screen was blank, and that the unit had shutdown.However, the unit was able to be immediately powered back on without issue, at which time, the blood within the extracorporeal circuit was returned to the patient.The clinic manager was not able to provide a reason for the blood loss experienced during this event.Following the event, the 2008t hd machine was removed from service for evaluation.The biomed and a fresenius regional equipment specialist (res) performed a machine evaluation.The fresenius res found that the machine¿s power supply fan was not running and ordered a replacement power supply.The biomed installed the replacement power supply which resolved the issue.The unit has been returned to service at the user facility without a recurrence of the event as reported.No parts are available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation.The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res).The res found that the machine¿s power supply fan was not running and ordered a replacement power supply.The biomed installed the replacement power supply which resolved the issue.The unit has been returned to service at the user facility without a recurrence of the event as reported.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.The investigation into the cause of the reported problem was able to confirm the failure mode.The res found that the power supply fan was not working which led to the device overheating, and then powering down.Therefore, the complaint has been deemed confirmed.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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 johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6236874
• MDR Text Key: 64342887
• Report Number: 2937457-2017-00020
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• 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: 190766
• Other Device ID Number: 00840861100910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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