BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILENT TECHNOLOGIES

    MDR report key: 304669 · Received November 9, 2000

    Report

    Report Number
    MW1020388
    Event Type
    Injury
    Date Received
    November 9, 2000
    Date of Event
    October 23, 2000
    Report Date
    November 9, 2000
    Manufacturer
    AGILENT TECHNOLOGIES HEALTH CARE SOLUTIONS GROUP
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 4/12/01: MFR RECEIVED LETTER DATED 3/15/01 ON 4/5/01 REGARDING THE AFOREMENTIONED VOLUNTARY REPORT, CONCERNING THE AGILENT TECHNOLOGIES NEONATAL SPO2 SENSOR. THE REPORT DESCRIBED A NEONATE PT THAT HAD A DARK IMPRESSION AND BOIL ON THE SKIN SURFACE WHERE THE SENSOR HAD BEEN APPLIED. ON 10/23/00, AGILENT RECEIVED A REPORT FROM HOSP THAT AFTER APPLYING THE M1193A SPO2 SENSOR ON A FOOT OF A NEONATE PT, AN INJURY WAS OBSERVED ON THE PT'S FOOT. DURING MFR'S INVESTIGATION, THE USER REPORTED THE FOLLOWING: THE HOSP PROTOCOL DICTATES THAT THE SPO2 SENSOR MUST BE ROTATED AND THE SKIN AREA CHECKED EVERY 8 HRS. THE ATTENDING NURSE THEN UPDATES THE PT'S RECORD. THIS PROTOCOL WAS FOLLOWED AND THE PT RECORDS WERE DOCUMENTED. IN CONTRAST TO THE HOSP'S PROTOCOL, AGILENT RECOMMENDS IN THE USER'S MANUAL AND THE SENSOR LABELING (COPIES OF THE RELEVANT PAGES ARE ATTACHED) THAT THE APPLICATION SITE SHOULD BE INSPECTED EVERY 2 TO 3 HRS TO ENSURE SKIN INTEGRITY AND CORRECT OPTICAL ALIGNMENT. IF A SENSOR IS APPLIED TOO TIGHTLY, PRESSURE NECROSIS MAY RESULT, WHICH IS SIMILAR IN APPEARANCE TO A BURN. IN ORDER TO AVOID SUCH PROBLEMS, THE USER'S MANUAL SPECIFIES THAT THE SENSOR STRAP SHOULD NOT BE STRETCHED MORE THAN 2.5 CM BEFORE IT IS PLACED IN THE GROOVE AND FED THROUGH THE SLOT. IN ADDITION TO TIGHT APPLICATION AND FAILURE TO REPOSITION THE SENSOR AS FREQUENTLY AS RECOMMENDED, OTHER FACTORS THAT MAY CAUSE OR CONTRIBUTE TO SKIN LESIONS ARE THE LOW LEVEL OF HEAT GENERATED BY THE LED'S AND RESIDUAL CLEANING AGENTS LEFT ON THE SENSOR BY THE USER. ALL OF THESE FACTORS MAY BE EXACERBATED BY PARTICULAR SENSITIVITIES OF THE PT'S SKIN. THIS IS WHY AGILENT'S LABELING RECOMMENDS FREQUENT INSPECTION OF THE APPLICATION SITE. IN THIS CASE, ALTHOUGH MFR WAS UNABLE TO EXAMINE EITHER THE M1193A SENSOR OR PHOTOGRAPHS OF THE SKIN LESIONS, INVESTIGATION CONCLUDED THAT THE REPORTED LESIONS WERE MOST CONSISTENT WITH PRESSURE NECROSIS AND THE USER DID NOT FOLLOW DIRECTIONS FOR USE CONCERNING THE FREQUENCY OF EXAMINING THE APPLICATION SITE AND REPOSITIONING THE SENSOR.

    Description of Event or Problem · 1

    THE NEONATE PT HAD BEEN ADMITTED TO THE HOSP FOR 12 DAYS. ON THE 11TH DAY, DURING THE ROTATION OF THE SENSOR PLACEMENT, WHEN THE ATTENDING PEDIATRIC INTENSIVE CARE UNIT NURSE CHECKED ON THE PT, SHE NOTICED A DARK IMPRESSION ON THE PT SKIN SURFACE, RIGHT FOOT, WHERE THE SENSOR WAS LOCATED. THE IMPRESSION MEASURED 3CM, AND WAS BROWNISH-RED COLOR AND HAD CREATED A BOIL THE NURSE IMMEDIATELY ROTATED THE SENSOR TO LEFT FOOT AND APPLIED SYLVADYN TO THE AFFECTED AREA. AFTER OBSERVATION OF THE SENSOR PLACED ON THE LEFT FOOT, SAME SKIN REACTION WAS OBSERVED AND THEREFORE, THE SENSOR WAS REMOVED PERMANENTLY FROM PT. (PRODUCT DISTRIBUTOR REPRESENTATIVES WERE PRESENT AT THE UNIT AT THE TIME OF EVENT AND MADE THEIR PRODUCT MALFUNCTION REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILENT TECHNOLOGIES NEONATAL SP02 SENSOR DQA AGILENT TECHNOLOGIES HEALTH CARE SOLUTIONS GROUP M1193A *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DAY Required Intervention