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

Catalog Number 191126

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

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 fresenius 2008t hemodialysis (hd) machine with a power plug that was observed with visible flame and smoking coming from it.It was confirmed the issued occurred while a patient was being treated on the machine, and it was confirmed the patient¿s blood was manually rinsed backed, and there was no blood lost.The smoke detectors at the clinic went off, and the clinic suite was evacuated.It was confirmed the machine had approximately 200 hours of use on it, and the power plug was the original fresenius part on the machine.The biomed confirmed the outlets at the clinic are not gfci outlets.It was confirmed that there was no damage to any other components on the machine.The biomed reported they were waiting on a replacement power supply to resolve the issue and return the machine to service.The power plug was reportedly returned to the manufacturer for analysis.Additional information was requested, but was not provided.If additional information is received, a supplemental report will be submitted.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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.

Manufacturer Narrative

Plant investigation: the device was returned to the manufacturer for physical evaluation.The power supply was received with the power cable cut.The power plug was not returned.An inspection on the power supply found the heater cable missing.Wires from capacitor (c1) were found to be unplugged from the power control board and the ground wire was not connected to the ground post of the power supply.There are no other discrepancies found during the initial inspection.A continuity check on the ground, neutral, and hot wires of the cut power cable found no discrepancies.A known-good power cable and heater cable were installed onto the power supply and the power supply was installed onto a test machine for testing.The machine powered on without alarms or failures.No damage occurred to the returned power supply and power cable during power up.The test machine completed a rinse program without damage to the returned power supply and cable.The test machine completed a heat disinfect program without damage to the returned power supply and power cable.The test machine was monitored in dialysis mode for 1 hour without discrepancies on the returned power supply and power cable.The machine passed the self-test program.The returned power supply functioned properly during testing.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.

• 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; 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: 8568094
• MDR Text Key: 143652293
• Report Number: 2937457-2019-01271
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2018
• 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