inforMED
MalfunctionLLK

N'VISION

Received Jan 12, 2016 · Event occurred Dec 16, 2015

Report 3007566237-2016-00231 · MDR key 5361823

Device

Generic name

Legging, Compression, Non-inflatable

Model number

8840

Catalog number

8840

Product problems

  • Improper or Incorrect Procedure or Method
  • Insufficient Flow or Under Infusion
  • Improper or Incorrect Procedure or Method
  • Insufficient Flow or Under Infusion

Patient

00054 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

INFORMATION WAS RECEIVED FORM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN 1,000MCG/ML, 130.2MCG/DAY AND INTRATHECAL FENTANYL 384MCG/ML, 100MCG/DAY, FOR INTRACTABLE SPASTICITY. FOLLOWING A CONCENTRATION CHANGED FOR THE BACLOFEN (TO 500MCG/ML) THE HCP PROGRAMMED THE PUMP BRIDGE BOLUS INCORRECTLY. THE OLD DRUG DESIRED DOSE SHOULD HAVE BEEN ENTERED AS 130.2MCG/DAY AND THE HCP ENTERED IT AS 100MCG/DAY, WHICH WAS THE DAILY DOSE OF THE NEW PRIMARY DRUG. THIS OCCURRED AT 11:44AM ON (B)(6) 2015. AT THE TIME OF THIS REPORT THE HCP WAS ON HER WAY TO SEE THE PATIENT AGAIN TO CORRECT THE ERROR AND PERFORM A "MODIFIED BRIDGE BOLUS." THIS CONSISTED OF DELIVERY OF 0.460ML OVER 84 HOURS AND 27 MINUTES. THE ACTUAL DOSE DELIVERED FROM THE BOLUS WOULD BE 460MCG OF THE OLD DRUG CONCENTRATION. THE PROGRAMMING WAS CORRECTED AND THERE WAS NO PATIENT OR THERAPY ISSUE. THE PATIENT'S MEDICAL HISTORY INCLUDES SPINAL CORD INJURY/DISEASE. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN ALL INFORMATION RELEVANT TO THE EVENT.