MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190766

Device Problem Device Maintenance Issue (1379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A user facility biomedical engineer (biomed) at a user facility reported that a fresenius 2008t hemodialysis (hd) machine was giving a "v104/108 stuck closed" message with an audible alarm at the select program screen.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this event.The biomed replaced the pressure transducer, which resolved the issue.During troubleshooting, the biomed had reported to have bled a lot when trying to use a screwdriver to replace the transducer.The biomed stated that his knuckles rubbed up against the sharp metal edges surrounding the transducer.He did not require medical intervention.The estimated blood loss (ebl) was not reported.The unit was sanitized and returned to service at the user facility without a recurrence of the event as reported.No parts were stated to be available to be returned to the manufacturer for physical evaluation.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.There was no on-site evaluation of the unit performed by a fresenius regional equipment specialist (res).The user facility biomedical technician (biomed) reported that his knuckles rubbed up against the sharp metal edges surrounding the transducer during machine service.He did not require medical intervention.The unit was sanitized and returned to service at the user facility without a recurrence of the event as reported.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-conformance's or any associated rework 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.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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: 7243918
• MDR Text Key: 99783166
• Report Number: 2937457-2018-00372
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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