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 Problems Mechanical Problem (1384); Reflux within Device (1522)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2020

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 (bmt) reported that a 2008k2 hemodialysis (hd) machine experienced a flow inlet error, high transmembrane pressure (tmp), and a saline bag backfill. The bmt verified there was no patient involvement associated with the reported issues. Upon further inspection of the machine, the bmt discovered that one of the ball bearings in the arterial hansen connector was missing. This was generating blockage on the arterial side of the dialysate, and effectively pushing the saline back into the bag. The machine was in the priming phase when this occurred. User error was not a contributing factor. The machine had over 20,000 hours on it at the time of the event. The machine did not give any filling programs. The bmt confirmed the machine had upgrades for the changes being effected (cbe) completed, and verified that the drain line length and height were within specification. A quick disconnect is reportedly used on the drain line. To resolve the reported issues, the bmt replaced the arterial hansen connector. The machine was subsequently returned to service. A provided photograph of the hansen connector showed that one of the ball bearings was missing, just as described. The used part was not 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: 9932961
• MDR Text Key: 194500157
• Report Number: 2937457-2020-00607
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

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

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse