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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN-2008K2 MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Numbness (2415)
Event Date 02/06/2018
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hemodialysis (hd) therapy utilizing the 2008k2 machine and the adverse event(s) of numbness, pain and vascular damage which required hospitalization and surgical intervention. The etiology of the event(s) is attributed to the over-inflation of a blood pressure cuff; however, the cause of the over-inflation is unknown; therefore, no causality can be fully established. Over-inflation of a blood pressure cuff has the potential to cause injury if not properly monitored. Based on the limited information available, the 2008k2 machine cannot be disassociated from the event(s). There are no treatment records available for review, and the machine was not returned to the manufacturer for functional compliance testing. It cannot be confirmed whether or not the machine malfunctioned with the information available. As such, a possible causal or contributory role in the patient¿s adverse event(s) cannot be excluded. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that the blood pressure cuff on a fresenius hemodialysis (hd) machine over inflated, causing the patient to sustain an injury to the veins on their right arm on (b)(6) 2018. The patient was subsequently hospitalized and suffered from severe pain and numbness in their hand. The patient underwent surgery to repair the damaged vein in their arm. The patient was hospitalized (b)(6) 2018. Additional information was requested, however to date not provided.
 
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Brand Name2008K2 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
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8283341
MDR Text Key134281271
Report Number2937457-2019-00283
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN-2008K2 MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received02/18/2019
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 Treatment Data
Date Received: 01/28/2019 Patient Sequence Number: 1
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