MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190766

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

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

Event Date 11/04/2021

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical support that a 2008t hemodialysis (hd) machine was displaying a ¿check acid connector¿ message while in rinse and heat disinfect cycles. When trying to calibrate the pressure transducers, the machine displayed a ¿valve (v) 105 stuck closed¿ message and a ¿v104/v108 stuck closed¿ message. During troubleshooting, the biomed found corrosion between valves 104 and 105. The biomed also identified heat damage and evidence of melting on valve 104. The wiring connected to valve 108 was also corroded. The biomed replaced the acid port pressure transducer, valve 104, and valve 105. After doing so, the 2008t machine began experiencing calibration issues. A ¿bibag: pressure calibration error¿ message appeared when they attempted to calibrate the regulator pressure. The biomed was advised by technical support (ts) to replace the bibag pressure transducer or the bibag interface board. The biomed replaced the bibag pressure transducer and was then able to calibrate the acid pump. However, the biomed could not get any conductivity pulled from the acid line. Up to this point, the biomed had also replaced the acid pump, the functional board, and the actuator test board. Later, the biomed replaced the bibag interface board and was then able to get the conductivity up. The biomed reported finding some charring on one of the leads on the back of the bibag interface board. The biomed stated there was no burning smell, smoke, arcing, sparks or flames. The machine has approximately 8,000 hours on it. No damage was identified on any other components. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test. Upon completion of the repair work, the machine was confirmed to be working. There were no parts available to be returned for physical evaluation as they were reportedly discarded. In addition, no photos were available for review. There was no patient involvement associated with the reported events.

Manufacturer Narrative

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

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 12887923
• MDR Text Key: 281382421
• Report Number: 2937457-2021-02354
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• 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: 12/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190766
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse