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U.S. Department of Health and Human Services

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

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MARVAO MEDICAL NEXSITE HD STEPPED TIP; HEMODIALYSIS CATHETER Back to Search Results
Catalog Number NEXHD1553201
Device Problem Malposition of Device (2616)
Patient Problems Bacterial Infection (1735); Fever (1858); Staphylococcus Aureus (2058)
Event Date 04/15/2016
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation because the device remains implanted; therefore an analysis of the complaint device could not be completed.A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.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.
 
Event Description
(b)(4): the nexsite device was successfully placed in this patient on (b)(6) 2016.On (b)(6) 2016, mild malposition of her catheter with inability to run her dialysis treatment was reported.The same catheter remained, the catheter was just untwisted and repositioned.The event resolved on the same date.On (b)(6) 2016, the patient experienced mild bacteremia with (b)(6) of unknown primary.The patient had a fever and wbcs of 21.4.Peripheral bloods showed (b)(6) while central bloods were not taken.While the source of the bacteremia was unknown, a uti or pneumonia was suspected.The exit site was clean, the tunnel tract was clean and when the antibiotics were discontinued, the catheter was still being used without problems.Vancomycin as given to treat the event and the event resolved on (b)(6) 2016.
 
Event Description
Additional information: it was confirmed that no urine analysis or culture was done on the patient.Chest x-ray demonstrated infiltrates felt to be consistent with pneumonia.
 
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Brand Name
NEXSITE HD STEPPED TIP
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MARVAO MEDICAL
innovation in business centre
gmit, dublin road
galway, H91 D CH9
EI  H91 DCH9
Manufacturer Contact
fiona geraghty
innovation in business centre,
gmit, dublin road
galway, galway H91 D-CH 9
EI   H91 DCH 9
91759301
MDR Report Key5771530
MDR Text Key48820467
Report Number3008110587-2016-00026
Device Sequence Number1
Product Code MSD
UDI-Device Identifier05391525640068
UDI-Public(01)05391525640068(17)161101(10)42551
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133796
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/13/2016
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? Yes
Device Operator Physician
Device Expiration Date11/01/2016
Device Catalogue NumberNEXHD1553201
Device Lot Number42551
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/13/2016
Initial Date FDA Received07/06/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/28/2016
Date Device Manufactured12/02/2015
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
ESCITALOPRAM
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age56 YR
Patient Weight138
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