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

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.

• 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 Key: 4548005
• MDR Text Key: 17293858
• Report Number: 3008110587-2015-00003
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121933
• Number of Events Reported: 1
• 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 Date: 03/31/2015
• Device Model Number: NEXHD1552801
• Device Lot Number: 36284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• 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 Age: 51 YR
• Patient Weight: 79