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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARVAO MEDICAL NEXSITE HD STEPPED; HEMODIALYSIS CATHETER

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MARVAO MEDICAL NEXSITE HD STEPPED; HEMODIALYSIS CATHETER Back to Search Results
Model Number NEXHD1552801
Device Problem Insufficient Information (3190)
Patient Problems Bacterial Infection (1735); Fever (1858); Staphylococcus Aureus (2058); Chills (2191)
Event Date 02/07/2015
Event Type  Injury  
Event Description
(b)(6) (prospective clinical evaluation) on (b)(6) 2015, this patient presented to the emergency department with a three day history of fever and chills.She was febrile and had leukocytosis.Cxr (chest x-ray), ua (urine analysis) and influenza swab were all unremarkable.Blood culture was taken and she was given ceftriaxone.She was admitted to hospital on this date and repeat blood cultures were taken.She was started on vancomycin.The patient's catheter was removed on (b)(6) 2015 due to positive blood cultures/positive bacteremia, and a temporary catheter was placed.There were no complications with removal and the device was disposed.The catheter tip was not cultured.Blood cultures isolated (b)(6) on (b)(6) 2015.Repeat blood cultures were negative.A tunnelled femoral catheter was placed on (b)(6) 2015 and the patient was discharged home from hospital to continue with antibiotics in her outpatient clinic for 2 weeks and resume her usual dialysis schedule.As of (b)(6) 2015, the patient is doing well and has no fever.She is dialyzing with a right femoral catheter.
 
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device has been disposed; therefore, an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirms that the lot met the specification requirements.No deviations that could affect product quality were found.Taking into consideration, the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.
 
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Brand Name
NEXSITE HD STEPPED
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MARVAO MEDICAL
innovation in business centre,
gmit, dublin road,
galway,
EI 
Manufacturer Contact
fiona geraghty
innovation in business centre
gmit, dublin road,
galway, 
EI  
91759301
MDR Report Key4548005
MDR Text Key17293858
Report Number3008110587-2015-00003
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121933
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/16/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date03/31/2015
Device Model NumberNEXHD1552801
Device Lot Number36284
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2015
Initial Date FDA Received02/26/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ASPIRIN; DILANTIN; NOVOLOG MIX; CARDURA; COREG; SIMVASTATIN; ERGOCALCIFEROL; HYDROCORTISONE TOPICAL CREAM; DILTIAZEM HYDROCHLORIDE; PHENERGAN; CALCIUM ACETATE
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age51 YR
Patient Weight79
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