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

Model Number 2008T

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

No parts were returned to the manufacturer for physical evaluation. The 2008t hemodialysis (hd) machine was evaluated at the facility by the fresenius regional equipment specialist (res). Machine functional checks were performed during the res on-site evaluation. The unit passed all functional checks without errors or problems. System self-test completed without issue. Functional testing performed by the res confirmed that the unit was operating properly. No system malfunction observed or identified; the unit worked per specification. The 2008t hd machine has been returned to service at the user facility without issue. 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 during the manufacturing process which could be associated with 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 was not able to identify any device issues that could be associated with the reported event and the complaint is unconfirmed. The evaluation onsite of the complaint device confirmed that the 2008t hd machine functioned fully as designed and met specification.

Manufacturer Narrative

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

Event Description

The biomedical technician at the user facility reported that a 2008t hemodialysis (hd) machine generated a 24v low alarm approximately fifteen minutes before the hd therapy was completed. The hd treatment was ended, and the blood within the extracorporeal circuit was partially returned. The patient's estimated blood loss (ebl) was noted as being approximately 200 cubic centimeters (cc). No patient adverse effects were experienced and no medical intervention was required as a result of this event. The patient's condition following the event was noted as being fine. Following the event, the machine was removed from service for evaluation. A fresenius regional equipment specialist (res) performed an on-site evaluation of the unit. The res was not able to duplicate the 24 volt error. However, the power supply was replaced as a precautionary measure. Functional testing performed by the res confirmed the system was operating properly. The unit has been returned to service at the user facility without issue. No parts were available to be returned to the manufacturer for evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6601146
• MDR Text Key: 160436248
• Report Number: 2937457-2017-00409
• 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: company representative,consum
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/22/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 2008T
• Device Catalogue Number: 190713
• 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: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse