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 02/07/2020

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 biomedical technician (biomed) reported noticing that a 2008k2 machine had internal wiring insulation that was breaking off and displayed signs of melting.The biomed stated that this issue could lead to conductivity and temperature issues, over time.To resolve the reported issue, the biomed replaced the conductivity sensor, and the two temperature sensors (temperature sensor 2 and temperature sensor 3).The wiring from all three components was exposed.There was no patient involvement associated with the reported issue.No sample was available to be returned 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; 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: 9772440
• MDR Text Key: 193637487
• Report Number: 2937457-2020-00410
• 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: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2009
• 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