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

Device Problem Pumping Problem (3016)

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

Event Date 07/01/2017

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

The clinic manager reported that the bloodlines had clotted during a patient treatment due to no movement of the blood although the blood pump was actively spinning at 400ml/min.The machine did not alarm.The clinic manager stated that the pressure parameters are reset and had expected the machine to alarm when this happened but there were no machine alarms.The clinic manager stated that the air in the arterial bloodline would be pulled off to show that the blood is moving, but the blood in the bloodlines after the blood pump does not move and clots within the circuit.There are no allegations of malfunction or defect with the dialyzer (unknown manufacturer) or bloodlines (medisystems).The patient did not experience any adverse reaction or injury.No medical intervention was required.The patient experienced blood loss (estimated volume is unknown) as the blood in the external circuit was clotted and was not returned to the patient.The patient completed treatment with a new set-up of supplies on the machine.The clinic manager stated that this occurred with five patients since (b)(6) 2017.The machine serial number, actual date of event, and patient information is unknown.One submission will be filed for each of the reported five patients from (b)(6) 2017 through the report date (reported in (b)(6) 2017).This submission documents the event on an unknown date, selected as (b)(6) 2017.The clinic manager stated that some of the machines¿ blood pump modules have been replaced by the facility biomedical technician.All machines are currently in service at this time.There are no parts available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the 2008t hemodialysis (hd) machine in question was not known.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure." p/n 500658; a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: 2008T HEMODIALYSIS MACHINE
• 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: 7001245
• MDR Text Key: 92059720
• Report Number: 2937457-2017-01134
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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