MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN-2008K2 MACHINE

Device Problem Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted. .

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 MACHINE
• 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: 9809216
• MDR Text Key: 193640039
• Report Number: 2937457-2020-00449
• 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: other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN-2008K2 MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 02/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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