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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190713
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2022
Event Type  malfunction  
Event Description
A fresenius field service technician (fst) was called onsite by a user facility to evaluate a 2008t hemodialysis (hd) machine that reportedly had blood in the internal transducer protector on the level detector module. Additional information was obtained through follow-up with the fst and the hd user facility. Initially, a facility representative indicated that a ¿bad set of blood lines¿ was used during a patient¿s treatment. The facility uses b. Braun blood lines that do not have an external transducer. The patient¿s treatment was reportedly completed on the machine, without interruption. Ten days later, during the priming phase for a different patient¿s treatment, the machine gave an unknown pressure alarm. The operator noticed blood from the transducer which had backed up into the b. Braun bloodline. The facility¿s charge nurse (cn) suspected that blood got into the transducer during the previous treatment. It was confirmed there was no patient injury or harm. The cn explained that their post-treatment cleaning procedure requires them to ¿look up into the transducer¿ to ensure it¿s clean, and thinks that this step might have been rushed. In the process, they overlooked the blood (less than 1 ml) that was within the transducer. During the fst¿s evaluation of the machine, blood was identified inside the internal transducer. To resolve the reported issue, the fst replaced the entire level detector module. The machine passed all functional tests after the repair was completed. The level detector module was returned for manufacturer evaluation. No patient information was provided.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14419833
MDR Text Key292217457
Report Number0002937457-2022-00788
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received05/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2018
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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