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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HEMODIALYSIS MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problem Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2017
Event Type  malfunction  
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. " a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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.
 
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Brand Name2008T HEMODIALYSIS MACHINE
Type of DeviceDIALYZER, 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 Key7001184
MDR Text Key192697436
Report Number2937457-2017-01131
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received11/13/2017
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

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