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

Model Number 2008T

Device Problems Thermal Decomposition of Device (1071); Smoking (1585); Sparking (2595)

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

Event Date 06/08/2017

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A biomedical engineer (biomed) at a user facility reported that the fresenius 2008t hemodialysis (hd) machine had a smell of smoke, and there was visible sparking at the power plug during a patient¿s treatment.Follow-up information with the biomed revealed that the event occurred at the end of the patient¿s treatment so the treatment was discontinued.The patient¿s blood was returned manually and there was no patient injury or adverse reaction as a result of this malfunction.Although the patient was removed from treatment early, there was no medical intervention required and the patient did not need additional treatment.The patient has since returned for regularly scheduled treatments with no further issues.The biomed stated that the power plug was observed to have been burned and blackened.There was no report of any damage to other components.The biomed stated that the burned plug was original to the machine and the machine has approximately 2,000 hours.The biomed stated that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed replaced the power plug.Following the part replacement, the system was restored to full functionality.The unit was returned to service at the user facility without a recurrence of the event as reported.The power plug is available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: the power plug was returned to the manufacturer for analysis with the cable cut off.A visual examination was performed on power plug which revealed signs of heat damage and pitting on the prong of the hot (black) terminal of the plug.In addition, the plastic mold appeared to have been melted.A functional resistance test was performed on the plug by measuring the resistance from end to end on each prong of the plug.The measurements found no discrepancies.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 non-conformances or any associated rework during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements and did not reveal any issues or problems related to the reported complaint.The investigation into the cause of the complaint was able to confirm the reported event.A visual examination of the power plug confirmed that the part sustained heat damage.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 c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6689874
• MDR Text Key: 79181237
• Report Number: 2937457-2017-00540
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2016
• 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