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 Pressure Problem (3012)

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

Event Date 10/27/2017

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

An area technical operations manager (atom) for a user facility reported that the fresenius 2008t hemodialysis (hd) machine was giving arterial pressure, venous pressure, and transmembrane pressure (tmp) alarms during patient treatment.The arterial drip chamber would run low or out of blood and the venous chamber would overfill and wet the venous transducer.The patient¿s blood clotted in the venous chamber, resulting in blood loss.There was no patient injury or adverse reaction reported.The patient¿s blood was returned and the staff changed the venous line and the patient completed treatment.The dialyzer is primed at 150ml/min.The machine is set-up with bloodlines and the venous chamber is primed.The arterial and venous transducer lines are clamped and hung from the pressure ports with the transducers attached.The machine self-test runs and when the patient arrives, the arterial and venous transducer lines are attached to the pressure ports and the hansen lines are connected to the dialyzer where the priming is completed.The dialyzer is inverted during the priming of the circuit.Following the event, the machine was removed from service for evaluation.The atom has troubleshooted the machine but has not identified the source of the issue.The machine continues to have the issue.The machine is currently in use 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

No parts were returned to the manufacturer for physical evaluation and there was no on-site service performed at the facility 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 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 by the manufacturer was not able to confirm the reported event.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• 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: 7058525
• MDR Text Key: 93574412
• Report Number: 2937457-2017-01241
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2017
• 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