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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tachycardia (2095); Burning Sensation (2146)
Event Date 02/24/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical review: there is no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation. Additionally, there is no allegation of a fresenius 2008t hd machine malfunction or deficiency related to the reported event.
 
Event Description
It was reported to fresenius that a hemodialysis (hd) patient experienced symptoms of a burning sensation in their chest and tachycardia during an hd treatment. After 2 hours and 37 minutes into the patient¿s treatment, the patient began experiencing these symptoms as their pulse rate increased within the range of 122 to 137 bpm. The treatment was discontinued, and the patient was placed on 100% oxygen through a non-rebreather mask. The patient was transported to the emergency department (ed) where it was found the patient¿s symptoms were caused by an undiagnosed cardiac condition that was unrelated to hd therapy. The patient was prescribed oral eliquis (unknown dose, frequency and duration) as a blood thinner and released from the ed to home on the same day. It was confirmed by the outpatient clinic physician that the patient¿s symptoms and the associated ed visit were unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s). The patient continues hd therapy on an in-center basis following this event with no further incident. Based on the available information, there was no indication of a serious injury, patient death, or other adverse event related to a fresenius product or other issue warranting further investigation.
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key11530920
MDR Text Key241424484
Report Number2937457-2021-00461
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number191126
Device Catalogue Number191126
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 Received03/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2018
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: 03/19/2021 Patient Sequence Number: 1
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