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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Alarm Not Visible (1022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/03/2018
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) and no parts were returned for failure analysis. The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation. As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. A batch records review was conducted by the manufacturer for the reported serial number. There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event. In addition, the device history records (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements. The device met all specifications for release. A review of the dhr did not reveal a probable cause for the customer complaint.
 
Event Description
A user facility clinical manager reported that the patient care technician (pct) saw discoloration inside the dialyzer dialysate port while rinsing the patient¿s blood. Blood leak test strips were used and came back positive for the presence of blood. The clinical manager stated that the fresenius 2008k2 machine did not alarm and was removed from service. The patient¿s blood was not rinsed back, and patient¿s estimated blood loss was approximately 300 ml. The patient did not experienced any adverse event, injuries or required medical intervention. The clinical manager stated that the dialyzer used was not a fresenius dialyzer, and could not provide the manufacturer. Additionally, the clinical manager stated that there was no blood leak observed from the dialyzer. The clinical manager stated that the in ¿house biomed looked at the machine and reported that no issues were found. The clinical manager stated that the machine has been returned to service without further issues. Additional patient demographics was requested; however not provided.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key7559052
MDR Text Key109751351
Report Number2937457-2018-01515
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 05/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/04/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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