MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190610

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2020

Event Type  malfunction  

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 that a 2008k2 machine experienced a low flow error and low transmembrane pressure (tmp) alarm.While troubleshooting the alarms, the biomed came across a wiring harness on valves 24, 25, and 26 which exhibited signs of heat damage.There was cracking and reported evidence of melting found on the wiring harness.After finding the damaged component, the biomed replaced the valves and the wiring harness.The biomed was unable to identify the exact cause for the low flow error and tmp alarms.During troubleshooting, the biomed loosened all the screws on the distribution board and tilted it forward to look for traces of corrosion; no corrosion was found.After putting the distribution board back in place and the powering up the machine, the issue had been resolved.The biomed could not duplicate the alarms.It was suspected there was a loose connection somewhere on the distribution board, and in the process of examining the distribution board for corrosion, the biomed was able to re-secure whatever connection(s) may have been loose.Other than the melting and cracking on the wiring harness, there were no other damaged components found.There was no burning smell, smoke, sparks, flames, or arcing.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.Upon follow, the biomed confirmed the machine was returned to service and has not experienced any further issues.There was no patient involvement associated with the reported event.No sample was available to be returned for evaluation as it was reportedly discarded.In addition, a photograph of the damaged component could not be provided.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 9695125
• MDR Text Key: 193109330
• Report Number: 2937457-2020-00282
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2009
• 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