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

Catalog Number 190713

Device Problem Pumping Problem (3016)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch will be submitted at the completion of this acitivity.

Event Description

It was reported the bloodlines clotted during a patient's treatment but the machine did not alarm.The machine is designed to alarm when either the venous or arterial pressures exceed set limits.During follow up with the nurse, it was learned the patient was dialyzing without the blood thinner heparin.Towards the end of the treatment, the nurse noted the extracorporeal circuit began to clot.The arterial pressure became more negative but stayed within the set alarm parameters.The venous pressure did not rise and the blood pump continued running.There appeared to be some issue from the arterial side of the dialysis access which affected the arterial pressure.The nurse thought the machine should have alarmed because of the clotting but it didn't because the alarm limits were not exceeded.The nurse noted blood clotting in the venous and arterial chambers of the bloodlines.The nurse terminated the treatment a bit early but could not return any of the patient's blood.The patient's estimated blood loss (ebl) was noted as being approximately 180 ml.There were no patient adverse effects experienced and no medical intervention was required as a result of this event.The patient continues on hemodialysis without issue.The machine was removed from service for evaluation by the facility biomedical technician (bmt).According to the nurse, the bmt explained because the alarm limits were not exceeded, the blood pump kept running as it should.No malfunction was found after evaluation by a fresenius regional equipment specialist (res) and the machine has been returned to service without a recurrence of this issue.The dialyzer and the bloodlines were not fresenius manufactured products.

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.No system issues were identified during the on-site evaluation.Functional testing performed by the res confirmed that the unit was operating properly.No malfunction of the 2008t hd machine observed or identified during the on-site evaluation.The unit 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 deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the material and process controls were within specification.The investigation was not able to identify any device issues that could be associated with the reported event.The evaluation of the complaint device confirmed that the 2008t hd machine functioned fully as designed and met specification.

• 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: 6258493
• MDR Text Key: 65032297
• Report Number: 2937457-2017-00039
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Other Device ID Number: 00840861100897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2011
• 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