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

Catalog Number 190371

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2021

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A biomedical technician (bmt) reported a 2008k hemodialysis machine powered down by itself during dialysis (setup) mode.The bmt stated the power logic board and actuator boards were burned and damaged.The bmt replaced both boards and the power logic board appeared to get damaged for a second time.The bmt was advised to swap the motherboard or the power supply, check all power cable connections for issues, and to unplug the actuator/sensor cables from the distribution board to isolate the electronics.Additional information was requested but was not received to date.

Event Description

A biomedical technician (bmt) reported a 2008k hemodialysis machine powered down by itself during dialysis (setup) mode.The bmt stated the power logic board and actuator boards were burned and damaged.The bmt replaced both boards and the power logic board appeared to get damaged for a second time.The bmt was advised to swap the motherboard or the power supply, check all power cable connections for issues, and to unplug the actuator/sensor cables from the distribution board to isolate the electronics.Additional information was requested but was not received to date.

Event Description

A biomedical technician (bmt) reported a 2008k hemodialysis machine powered down by itself during dialysis (setup) mode.The bmt stated the power logic board and actuator boards were burned and damaged.The bmt replaced both boards and the power logic board appeared to get damaged for a second time.The bmt was advised to swap the motherboard or the power supply, check all power cable connections for issues, and to unplug the actuator/sensor cables from the distribution board to isolate the electronics.Additional information was requested but was not received to date.

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.

• Brand Name: 2008K HEMODIALYSIS SYS. OLC/DIASAFE PLUS
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 13117977
• MDR Text Key: 282964063
• Report Number: 2937457-2021-02528
• Device Sequence Number: 1
• Product Code: KDI
• 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: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 02/02/2022
• Supplement Dates FDA Received: 01/04/2022; 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2008
• 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
• Patient Ethnicity: Non Hispanic