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 Problem (3016)

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

Event Date 06/15/2017

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 the patient experienced blood loss while undergoing hemodialysis (hd) treatment on a 2008t hd machine.The biomed reported that the blood pump tubing segment was pulled up into the blood pump, wrapped around the rotor and tore.The total estimated blood loss (ebl) was noted as being approximately one unit of blood.The hd treatment was discontinued approximately six minutes early.There was no blood observed on the blood pump tubing holder.Following the event the system was removed from service for evaluation.A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine.The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly.The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues.The biomed informed the res that the tubing retainer/release was replaced prior to the res inspection.The unit is reportedly approved to be returned to service at the user facility.No parts are reported to be available to be returned to the manufacturer for evaluation.No further information has been made available at this time.

Manufacturer Narrative

Plant investigation: 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).The res inspected the rollers, tubing guides, and tubing retainer/release, which were intact and functioning properly.The res verified pumping flow and verified that the tubing set could be removed and replaced multiple times without any issues.The user facility biomedical technician (biomed) informed the res that the tubing retainer/release was replaced prior to the res inspection.The unit is reportedly approved to be returned to service at the user facility.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 identified 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.The res verified that the machine was operating properly as the biomed reportedly replaced the tubing retainer/release prior to res inspection of the machine.Therefore, the complaint is not confirmed.

• 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: 6724699
• MDR Text Key: 80439520
• Report Number: 2937457-2017-00595
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2008T
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2011
• 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