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

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2020

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 a burning/smoke smell during the heat disinfect of 2008t machine.There was no patient involvement associated with the event.Further evaluation revealed evidence of melting and burn damage on the bibag interface board, the actuator test board, and the ribbon cable to the bibag interface board.Follow up with the biomed confirmed the reported damage.The biomed wasn¿t sure what triggered (or caused) the heat related damage.There was no arcing, visible smoke, and no sparks or flames.No damage was identified on any other components.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet, and there was no previous history of the machine failing the electrical leakage test.There were approximately 1,200 hours logged on the machine at the time of the event.The biomed called a fresenius field service technician (fst) onsite to repair the machine.To resolve the reported issue, the fst replaced the bibag interface board, the bibag interface cable, the actuator test board, and the actuator cable.While at the facility, the fst elected to perform hardware upgrades on the machine and replaced the transducers as a proactive measure.The following parts were also replaced: the pressure transducer, the bibag pressure transducer, the acid port pressure transducer, and the chamber full switch.During the fst¿s inspection, a hose leak was identified at bibag valve 100.The fst trimmed and adjusted the tubing to correct the problem.During functional checks, the temperature was found to be slightly below the set point (0.6 below); the low temperature was calibrated to resolve the issue.All other functional checks passed and the machine was subsequently returned to service.The fst reportedly has the damaged parts and intends to send them back for evaluation.

Manufacturer Narrative

Additional information: device evaluated by mfr: 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).The fst confirmed there was burning and melting damage on the bibag interface board, the actuator test board, and the ribbon cable to the bibag interface board.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.The fst resolved the reported issue by replacing the parts impacted by the heat-related damage.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
• MDR Report Key: 9974823
• MDR Text Key: 188114455
• Report Number: 2937457-2020-00699
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1