MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 2008T

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 07/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility's biomedical technician (bmt) reported a burning smell followed by visible smoke, coming from a hemodialysis machine.The bmt also reported visible burn marks (charring) on the actuator/test board.No sparks or flames were observed.No patient was adversely effected or impacted, as this occurred during power-up.The bmt pulled the machine from use.An on-site service repair was scheduled from a fresenius regional equipment specialist (res).The res evaluated the machine and confirmed the actuator/test board to be physically damaged.This was a result of an exposed ribbon cable, from the acid pump, shorting to the chassis of the machine, while the bmt was rebuilding the bicarb pump.The actuator/test board was replaced.There was no physical damage to the acid pump, however, due to the exposed wiring, it was replaced as well.No parts are available to be returned to the manufacturer for failure analysis.Following part replacement, the system was restored to full functionality.Functional testing performed by the res confirmed that the unit was operating properly.The unit has been returned to service at the user facility with no further issues being reported.

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 performed a visual examination of the unit which confirmed damage to ic24 on the actuator/test board.The res replaced the actuator/test board to resolve the issue.Additionally, the acid pump was replaced as a precautionary measure.Following the part replacements, the system was restored to full functionality.Functional testing performed by the res confirmed that the system was operating properly.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.In addition, the device history record (dhr) review confirmed the labeling, 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¿s attributed the failure to be the result of an exposed ribbon cable from the acid pump, shorting to the machine chassis, while the bmt rebuilt the bicarb pump.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): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5879420
• MDR Text Key: 53049501
• Report Number: 2937457-2016-00887
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2016
• 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
• Date Manufacturer Received: 08/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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