MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T GEN 2 BIBAG WITHOUT CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190895

Device Problem Inadequate Ultra Filtration (1656)

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

Event Date 11/16/2017

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).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 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 biomedical technician (biomed) at a user facility reported that at the end of a patient¿s hemodialysis (hd) treatment using a fresenius 2008t hd machine, there was too much ultrafiltration (uf) fluid removal.It was stated that the patient¿s uf goal was 3400ml, but a total of 5100ml of fluid was removed.There was no patient injury.The biomed stated that the machine passed all tests prior to treatment.Following the event, the machine was removed from service for further evaluation.The on-site biomed verified the uf pump met calibration requirements.The biomed verified all machine operations and did not make any repairs.The machine was returned to service at the user facility without a recurrence of the event as reported.The biomed reported that the issue was due to operator error.No parts are available to be returned to the manufacturer for evaluation.Follow-up information received from the nurse confirmed that at some point during the patient¿s treatment, a staff member adjusted the uf.No specific information regarding the adjustment was available.The nurse stated that the patient had complained of cramping approximately 30 minutes prior to the end of treatment.The nurse terminated the treatment at that time and did not re-start treatment as there was only 30 minutes remaining.The patient¿s weight after treatment was lower than the expected weight by more than 1kg.There was no medical intervention or actions taken in response to the excessive uf removal.The patient was not treated for the reported cramping and did not experience any other symptoms.The patient is currently doing well and has been able to complete all scheduled hd treatments without any further problems.

• Brand Name: 2008T GEN 2 BIBAG WITHOUT 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: 7112007
• MDR Text Key: 95744877
• Report Number: 2937457-2017-01327
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100927
• UDI-Public: 00840861100927
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2016
• 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