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

Catalog Number 190610

Device Problems Thermal Decomposition of Device (1071); Corroded (1131)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: although it was stated that the complaint device was available to be returned to the manufacturer for physical evaluation, to date none has been received. The reported complaint was not confirmed as the complaint device was not returned to the manufacturer for evaluation. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. 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. 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. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A biomedical technician (biomed) at a user facility reported that while troubleshooting the 2008k2 hemodialysis machine for conductivity issues, it was noted that the wiring harness was corroded due to heat damage. The biomed stated that the insulation on the temperature sensors was melted due to heat damage and eventually became brittle and was crumbling off. The biomed stated that the temperature control thermistor insulations were melted and burnt. The biomed stated that it is unsure if a patient was on the machine or not at the time of the conductivity issues; however confirmed that there was no adverse events, medical intervention or injuries reported. The biomed replaced the temperature sensors. The machine has been returned to service at the user facility without recurrence of the reported issue. The complaint device is available to be returned to the manufacturer for evaluation.

• 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; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7572910
• MDR Text Key: 110181300
• Report Number: 2937457-2018-01586
• Device Sequence Number: 1
• Product Code: KDI
• 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

• Type of Report: Initial
• Report Date: 06/06/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse