MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number UNKNOWN- 2008T MACHINE

Device Problem Inadequate Ultra Filtration (1656)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

A user facility biomedical technician (biomed) reported to a fresenius clinical support specialist that a 2008 machine (model unknown) which was recently upgraded with bluestar software is not holding the programmed ultrafiltration (uf) goal and time settings. The settings were programmed to a uf goal of 2. 5 liters and a uf time of 4 hours. The biomed stated that a second person visually verified the programmed settings to ensure that they were correct. However a few minutes after the initiation of treatment the machine reverts back to the default settings of 3 liters and 3 hours. Additional information was requested, however a response has not been received. There was no indication that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue. It was indicated on the initial report that the patient was not able to complete treatment with the fresenius products and devices that were originally provided. No parts were returned to the manufacturer for a physical evaluation.

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 could not be performed as the reported serial number was not reported. 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.

• Brand Name: UNKNOWN-2008
• 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: 14251544
• MDR Text Key: 290398024
• Report Number: 0002937457-2022-00706
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• 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,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNKNOWN- 2008T MACHINE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 05/03/2022
• 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