MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Melted (1385)

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

Event Date 10/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a ¿pre/post temp out of range¿ error occurred when they tried to perform temperature sensor calibrations on a 2008 hemodialysis (hd) machine.The biomed had just completed a software upgrade on the machine.To resolve the reported issue, the biomed replaced the post temperature sensor.The biomed reported that the wires around the post temperature sensor were melted and eroded.The biomed confirmed there were no signs of any burn marks, smoke, sparks, or flames.The biomed said the wiring casing material is low quality and had melted off, which then caused the wiring to oxidize and become ineffective.The biomed stated the material used for this wiring casing is very flexible and prone to heat damage.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed stated there were 18,996 hours on the machine at the time of the repair.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photos were also unavailable.There was no patient involvement associated with the reported event.

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 user facility biomedical technician (biomed) reported to fresenius technical support (ts) that a ¿pre/post temp out of range¿ error occurred when they tried to perform temperature sensor calibrations on a 2008t hemodialysis (hd) machine.The biomed had just completed a software upgrade on the machine.To resolve the reported issue, the biomed replaced the post temperature sensor.The biomed reported that the wires around the post temperature sensor were melted and eroded.The biomed confirmed there were no signs of any burn marks, smoke, sparks, or flames.The biomed said the wiring casing material is low quality and had melted off, which then caused the wiring to oxidize and become ineffective.The biomed stated the material used for this wiring casing is very flexible and prone to heat damage.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The biomed stated there were 18,996 hours on the machine at the time of the repair.The replaced parts were not available to be returned for evaluation as they were reportedly discarded.Photos were also unavailable.There was no patient involvement associated with the reported event.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 12825125
• MDR Text Key: 284004363
• Report Number: 2937457-2021-02299
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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 Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2013
• 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