MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 190713

Device Problem Melted (1385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility biomedical technician (biomed) reported that a 2008t hemodialysis machine had a melted ultrafiltration (uf) check valve. The biomed stated water was leaking from the back of the machine during heat disinfect. There was no patient involvement associated with the event. The biomed traced the leak to the ultrafiltration (uf) check valve. The biomed stated the check valve had come apart and was melted. The biomed stated the damage must have occurred from repeated heat disinfect cycles. No damage was identified on any other components. The biomed confirmed there was no burning smell or burn damage found. Additionally, there were no signs of any smoke, sparks, or flames. The biomed fixed the machine by replacing the check valve. The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test. The biomed stated the machine has approximately 22,000 to 24,000 hours on it. It was confirmed the machine was returned to service. Photographs of the damaged check valve were not available. The biomed stated the part would be returned for evaluation via returned goods authorization (rga).

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: jason busch ; 920 winter st; waltham, MA 02451 ; 9043166958
• MDR Report Key: 14190253
• MDR Text Key: 290140729
• Report Number: 0002937457-2022-00674
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 190713
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse