BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    MDR report key: 5709963 · Received June 9, 2016

    Report

    Report Number
    2023988-2016-00015
    Event Type
    Malfunction
    Date Received
    June 9, 2016
    Date of Event
    May 25, 2016
    Report Date
    May 25, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 07/25/2016. THE DEVICE WAS NOT RETURNED FOR EVALUATION SINCE THE CUSTOMER HAD DISCARDED THE CATHETER. INTEGRA SHIPPED A TOTAL OF (B)(4) 110-4B TO (B)(6) HOSPITAL SINCE JUN 1ST OF 2015; LOT NUMBERS ARE: LOT #S: 111E00258073, 3050RX316171; MFG DATES: 23-MAR-2016, 14-OCT-2014, 19-MAR-2015; EXP. DATES: 28-FEB-2019, 30-SEP-2017, 31-JAN-2018. A REVIEW OF BATCH HISTORY RECORDS INDICATE THAT NO ABNORMALITIES RELATE TO REPORTED INCIDENTS; LOTS MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS. IN THE PAST 12 MONTHS ((B)(4) 2015 THROUGH (B)(4) 2016) THERE WERE (B)(4) CONFIRMED COMPLAINTS WITH THIS COMPLAINT CODE ((B)(4)) AND ((B)(4)) CATHETERS SOLD, THIS CALCULATES TO AN INCIDENCE RATE OF (B)(6). THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT RETURN EITHER DEVICES FOR EVALUATION. IT WAS REPORTED THAT BOTH CATHETERS WERE DISCARDED. A REVIEW OF THE CUSTOMER¿S SALES ORDERS FOUND A TOTAL OF (B)(4) SHIPPED TO THIS CUSTOMER, WHICH INCLUDES THREE CATHETER LOTS. A REVIEW OF THE LOTS DEVICE HISTORY RECORDS FOUND NO ANOMALIES AND THE CATHETERS MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO REPORTS (SAME PATIENT). THIS REPORT IS IN REGARDS TO THE 2ND CATHETER. LINKED TO MFG REPORT NUMBER: 2023988-2016-00016. CUSTOMER STATED THAT A PATIENT CAME INTO FACILITY AND HAD A CAMINO ICP BOLT IMPLANTED IN EMERGENCY ROOM (ER). WHEN THE PATIENT MADE THEIR WAY UP TO INTENSIVE CARE UNIT (ICU), THE MONITOR WAS READING A NEGATIVE PRESSURE VALUE. NO PATIENT INJURY WAS REPORTED. HOWEVER, THEY THREW AWAY THAT CATHETER AND IMPLANTED A SECOND ANOTHER - WHICH THEY ALSO FIGURED WAS NOT WORKING CORRECTLY. THE SECOND CATHETER WOULD NOT GET LOWER THAN THE NUMBER "18" WHEN TRYING TO CALIBRATE IT TO "0". THE STAFF DISPOSED OF THE CATHETERS. SURGERY DELAY OF 15 MINUTES WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370530 OLM INTRACRANIAL PRESSURE MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1