• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Fluid Leak (1250)
Patient Problems Anemia (1706); Dehydration (1807); Unspecified Infection (1930); Dizziness (2194); Electrolyte Imbalance (2196); Anxiety (2328)
Event Date 05/11/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
On (b)(6) 2018, a copy of a voluntary medwatch was received from a hemodialysis (hd) clinic reporting that patient on hemodialysis (hd) for renal replacement therapy (rrt) experienced an adverse event during treatment. After review of the medwatch and medical records received 06/05/2018, this patient came to the hd clinic on (b)(6) 2018 for a scheduled two hour and 45 minute of hd treatment. Pre-dialysis vital signs were blood pressure (bp) 146/95, pulse 81, respirations (resp) 20, temperature 96. 2°. The patient reported feeling dizzy prior to initiation of therapy, but demanded to come to treatment. The patient¿s therapy was initiated at 1016 hours without any issues. Approximately fifty minutes into treatment (1101 hours), the patient reported feeling dizzy, anxiety, sense of impending doom and lightheadedness. The patient bp was documented as 131/69 and pulse 84. At that time, the fresenius 2008t machine began to alarm (unspecified alarm) at which point the venous blood was noted to be black in color and clotted. The machine indicated that 338ml of fluid had been removed. The patient¿s arterial blood was then returned and she was administered 450ml normal saline (medwatch states 700ml). The patient requested to go to the hospital and 911 was called for emergency medical services (ems). At this time (1107 hours) the treatment was discontinued and the venous line was not returned. Vitals prior to transport were recorded as bp 152/96, pulse 75, resp 18. The patient was transported to the emergency room (er) via ems where she was evaluated for dizziness and nausea. The patient was diagnosed with dialysis disequilibrium syndrome, dehydration, anemia, electrolyte abnormality, hyperkalemia, dysrhythmia, and infection (unspecified). The patient¿s lab results were consistent with her esrd and potassium level showed within normal limits (4. 0mmol/l). An ekg does not show any changes. Nephrology was consulted and it was determined that the patient could return to hd therapy for her next scheduled treatment on (b)(6) 2018 and that no additional treatment was required. The patient¿s condition was improved and she was discharged to home approximately five hours after admission to the er. No hospital course is known. Upon follow up, the clinical manager reported that patient¿s estimated blood loss (ebl) was approximately 200 ml. Additionally, the clinical manager confirmed that the patient has returned to her scheduled hd treatment with no reported issues. Upon inspection of the 2008t hemodialysis machine by the biomedical engineer (biomed), a small hole was noted in the line returning to the machine from the blue hansen connector. The machine had passed functional testing prior to initiation of hd treatments. Functional testing was done by the biomed and the machine passed testing. The machine currently remains sequestered until inspection by a fresenius regional equipment specialist (res). Additional information obtained through the biomed documented that there was no hemolysis experienced by the patient. Per the biomed, the hose clamp for the dialysate hose has sharp edges that are cutting into the silicone resulting in leaks.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key7580458
MDR Text Key110447869
Report Number2937457-2018-01650
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190713
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 Received06/18/2018
Was Device Evaluated by Manufacturer? No
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: 06/07/2018 Patient Sequence Number: 1
-
-