MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problem Thermal Decomposition of Device (1071)

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

Event Date 05/04/2022

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 field service technician (fst) reported to fresenius that a 2008t machine had damage to power control board due to a power surge. Preventative maintenance was performed on the machine and it was found that the resistor of the power control board had been burnt and scorched. The power supply assembly was replaced and the machine and to power back on without issue. The machine was tested and returned to service without further issue. Upon follow-up the fst confirmed there was no smoke or burning smell that was reported by the facility. The fst stated there was no patient involvement, no harm or adverse event reported. The machine was successfully repaired and placed back in service without further issue.

Event Description

A field service technician (fst) reported to fresenius that a 2008t machine had damage to power control board due to a power surge. Preventative maintenance was performed on the machine and it was found that the resistor of the power control board had been burnt and scorched. The power supply assembly was replaced and the machine and to power back on without issue. The machine was tested and returned to service without further issue. Upon follow-up the fst confirmed there was no smoke or burning smell that was reported by the facility. The fst stated there was no patient involvement, no harm or adverse event reported. The machine was successfully repaired and placed back in service without further issue.

Manufacturer Narrative

Correction: plant investigation: no parts were returned to the manufacturer for physical evaluation. However, an on-site evaluation was performed by a fresenius field service technician (fst). To resolve the reported issue, the fst replaced the power supply assembly to resolve the issue. 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 able to confirm the reported failure mode. During the machine inspection, the fresenius fst identified the resistor of the power control board had been burnt and scorched. Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• 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 Key: 14317325
• MDR Text Key: 291191153
• Report Number: 0002937457-2022-00747
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse