MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

Device Problems Thermal Decomposition of Device (1071); Melted (1385)

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

Event Date 02/18/2021

Event Type  malfunction  

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 a wire inside the fresenius 2008k2 machine that connected the temperature sensor to a conductivity cell had melted.The melted wire was noticed during inspection.The machine initially failed the self-test for negative stabilization and displayed a temperature of 95 degrees celsius (c).The biomed found that water came into contact with the wiring which caused it to short and melt.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 32,000 hours and the wiring was original to the fresenius machine.The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with melted wire.The biomed replaced the temperature sensor to resolve the burn damage and replaced the pressure release valve to resolve the negative stabilization failure.The unit was returned to service at the user facility without issue and without reoccurrence of the event.The temperature sensor was discarded by the biomed and is not available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11437290
• MDR Text Key: 238413953
• Report Number: 2937457-2021-00380
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• 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
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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