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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190895
Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2022
Event Type  malfunction  
Event Description
A biomedical technician (biomed) at a user facility reported that the power supply of a fresenius 2008t hemodialysis (hd) machine had sustained burn damage.The burned power control board was initially noticed during machine repair after the machine was pulled from service for failing to power on.The biomed initially observed blown fuses on the board and attempted to replaced them and reboot the machine at which point the power supply sustained further burn damage.The biomed stated that the fuses reblew, the power control board burned, the capacitor charred, a yellow piece projected from the machine, and the wire connecting to the power switch melted.The biomed confirmed that a burning smell, smoke, spark, flame, and arcing were observed.The biomed stated that there was not enough smoke produced by the machine to trigger a facility smoke detector.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 13,715 hours and the power supply was the original fresenius part on the machine.The biomed confirmed that the machine does not have a history of failing the electrical leakage test.The biomed confirmed that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned power supply.The biomed stated that a replacement power supply was ordered and received.The machine remains out of service pending repair.The power supply is available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 identified during the manufacturing process which could be related to 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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
A biomedical technician (biomed) at a user facility reported that the power supply of a fresenius 2008t hemodialysis (hd) machine had sustained burn damage.The burned power control board was initially noticed during machine repair after the machine was pulled from service for failing to power on.The biomed initially observed blown fuses on the board and and attempted to replaced them and reboot the machine at which point the power supply sustained further burn damage.The biomed stated that the fuses reblew, the power control board burned, the capacitor charred, a yellow piece projected from the machine, and the wire connecting to the power switch melted.The biomed confirmed that a burning smell, smoke, spark, flame, and arcing were observed.The biomed stated that there was not enough smoke produced by the machine to trigger a facility smoke detector.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 13,715 hours and the power supply was the original fresenius part on the machine.The biomed confirmed that the machine does not have a history of failing the electrical leakage test.The biomed confirmed that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned power supply.The biomed stated that a replacement power supply was ordered and received.The machine remains out of service pending repair.The power supply is available to be returned to the manufacturer for physical evaluation.
 
Event Description
A biomedical technician (biomed) at a user facility reported that the power supply of a fresenius 2008t hemodialysis (hd) machine had sustained burn damage.The burned power control board was initially noticed during machine repair after the machine was pulled from service for failing to power on.The biomed initially observed blown fuses on the board and attempted to replaced them and reboot the machine at which point the power supply sustained further burn damage.The biomed stated that the fuses reblew, the power control board burned, the capacitor charred, a yellow piece projected from the machine, and the wire connecting to the power switch melted.The biomed confirmed that a burning smell, smoke, spark, flame, and arcing were observed.The biomed stated that there was not enough smoke produced by the machine to trigger a facility smoke detector.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.The machine has approximately 13,715 hours and the power supply was the original fresenius part on the machine.The biomed confirmed that the machine does not have a history of failing the electrical leakage test.The biomed confirmed that the machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned power supply.The biomed stated that a replacement power supply was ordered and received.The machine remains out of service pending repair.The power supply is available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
Additional information: h10 (plant investigation) plant investigation: photographs of the sample were provided to the manufacturer which identified the reported issue.The reported failure mode was able to be confirmed.
 
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Brand Name
2008T GEN 2 BIBAG WITHOUT CDX
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14743528
MDR Text Key294372913
Report Number0002937457-2022-00995
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100927
UDI-Public00840861100927
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 07/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190895
Device Catalogue Number190895
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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