BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROMONITOR BASIC KIT

    MDR report key: 3890099 · Received June 24, 2014

    Report

    Report Number
    1226348-2014-11728
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 13, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    GWM
    PMA / PMN Number
    PK914479
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE SUPPLIER PERFORMED THIS EVALUATION. DURING EVALUATION A REVIEW OF QUALITY RECORDS WAS CONDUCTED AND PRIOR TO DISTRIBUTION THIS DEVICE MET ALL MANUFACTURING AND QUALITY TESTING/INSPECTION SPECIFICATIONS. THE CATHETER WAS EVALUATED AND THE FOLLOWING OBSERVATIONS NOTED: NO VISIBLE DAMAGE TO THE MILLAR SENSOR; SENSOR IS FUNCTIONAL. CATHETER MATERIAL SEVERELY KINKED 4CM FROM SENSOR CASE. THE DEVICE FAILED NOISE TEST - READING WAS OFF SCALE. IT SHOULD BE =/< 0.35MMHG. NO FURTHER TESTING POSSIBLE. MFG. DATE: 2/25/14. BASED ON THE ABOVE EVALUATION, SUPPLIER WAS ABLE TO CONFIRM THE COMPLAINT. HOWEVER, THE CAUSE(S) OF THE FAILURE COULD NOT BE DETERMINED. NOTE THAT THE FIVE ICP EXPRESS CABLES P/N 82-6636 AND FIVE ICP EXPRESS MONITORS P/N 82-6634 REPORTED IN THIS COMPLAINT BY THE CUSTOMER WERE NOT RETURNED TO CODMAN FOR EVALUATION. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: ON 6/21/14 CUSTOMER REPORTED: THE FIVE ICP EXPRESS UNITS MENTIONED IN THE TEXT HAS NOT BEEN SENT TO YOU. THEY WERE CHECKED BY THE ENGINEERS AT THE HOSPITAL WITH THE RESULT "NO TECHNICAL ERRORS ARE IDENTIFIED". THE PRODUCT RELATED TO THE REPORT IS THE MICROSENSOR, WHICH HAS BEEN SENT TO YOU TOGETHER WITH THE REPORT. ON 6/23/14: CUSTOMER WAS ASKED TO CLARIFY THE TOTAL NUMBER OF ICP EXPRESS BOXES AND TOTAL NUMBER OF CABLES USED. ON 6/23/14: RESPONSE FROM CUSTOMER REGARDING NUMBER OF CABLES/ICP EXPRESS BOXES: (B)(4) FOR CASE ID (B)(4). HOW MANY ICP EXPRESS UNITS IN TOTAL WERE USED ON THIS PATIENT? ANSWER: DUE TO MY COUNTING, 5 UNITS IN TOTAL. UNIT NR 5 WAS USED AFTER THE SECOND IMPLANTATION AND WAS STILL IN USE WHEN THE REPORT WAS WRITTEN. HOW MANY CABLES IN TOTAL WERE USED ON THIS PATIENT? ANSWER: 5 CABLES. THERE IS NO INFORMATION IN THE REPORT OF THESE UNITS BEING CLEARED BY THE TECHNICIANS. I WILL EMAIL MY CONTACT AT THE HOSPITAL TO GET CONFIRMATION ABOUT THIS.

    Description of Event or Problem · 1

    THE FIRST ICP-READING IS 25MMHG. AFTER LESS THAN ONE HOUR MINUS READINGS ARE REGISTERED . THREE HOURS AFTER IMPLANTATION THE READINGS START TO VARY FROM 0-139 MMHG. THEY TRIED 5 DIFFERENT ICP EXPRESS AND GOT THE MESSAGE "TRANSMISSION ERROR." SIX HOURS AFTER IMPLANTATION THE PATIENT GETS A NEW MS IMPLANTED EXTRA SURGERY PERFORMED TO IMPLANT NEW SENSOR SHORT VERSION OF THE TRANSLATION, ONCE THE FULL TRANSLATION IS DONE, I WILL SEND IT IN . (DURING USE ON PATIENT) WHAT ACTION WAS TAKEN/REQUIRED TO MANAGE THE PROBLEM DURING THE PROCEDURE? WITH SAME LIKE PRODUCT. (B)(6) 2014, ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: MALE BORN -1971. OCCASION OF CARE ICU (B)(6), 06:05 AND ONGOING. PATIENT HAS NO KNOWN INFECTIOUS DISEASES. 07:06 CT. 10:00 MRI (BACK TO ICU 12:25)AM-PERSONAL: 13:40 FIRST REGISTERED ICP-VALUE IS 13 MMHG. NO DISORDERS IS NOTED. PM-PERSONNEL: 15:00 A VALUE OF 21 IS REGISTERED. IT HAS INCREASED FAST FROM A STABLE VALUE OF 15 MMHG. DOCTOR / NURSE IN CHARGE CONTACT THE NEUROSURGEON ON CALL TO REPORT THAT THE ICP-READINGS ARE HIGHER THAN BEFORE. THE NEUROSURGEON ON CALL ASKS THEM TO CHANGE TO ANOTHER ICP EXPRESS AND RE-ZERO, AS THEY DO NOT TRUST THE READINGS FROM/VIA THE CODMAN MONITOR. 15:53 BEDSIDE PULM AT ICU. A NURSE ENTERS THE ROOM TO HELP WITH ZEROING. SHE RE-ZEROES AND THE ICP INCREASE TO 190 MMHG. SHE THEN PULLS OUT THE CABLE AND START FROM THE BEGINNING. ZEROES AND GETS -99 ON THE ICP EXPRESS. 16:28 NEUROSURGEON ON CALL COMES AND RETRIEVES A NEW ICP EXPRESS AND CABLE. RESTART, CONFIRMS ZERO REFERENCE NUMBER AND GETS APPROXIMATELY THE SAME VALUES AS BEFORE, THAT IS 24-26 MMHG. THEY THEN DON´T TAKE ANY FURTHER ACTIONS TOWARD THE EQUIPMENT, AND ACCEPTS THE ICP-READING AS CORRECT. INSTEAD THEY TRY TO SEDATE MORE, BUT IT IS NOT SHALLOWNESS THAT CAUSES THE INCREASE IN ICP. (RASS-5, PUPILS DO NOT REACT TO LIGHT, VASOACTIVE DRUGS AND VOLUME ARE GIVEN TO STABILISE A CIRCULATION). 17:49 PATIENT IS TURNED 21:50 TURNED, WASHED, WEIGHTED. NIGHT-PERSONNEL: 22:32 THEY ONCE AGAIN HAVE PROBLEMS WITH THE ICP-MEASUREMENT. ICP-VALUE ON ICP EXPRESS AND ON THE PHILIPS MONITOR INCREASES FROM ABOUT 22 TO 198 MMHG. AT THIS POINT NO ACTIVITY IS TAKING PLACE AT THE PATIENT OR IN THE ROOM. THE SCRUB NURSE IS OUT, AND THE NURSE IS SITTING ALONE BY THE COMPUTER. NEUROSURGEON ON CALL IS CONTACTED. ICP EXPRESS AND CABLE IS CHANGED AND THE EQUIPMENT IS ZEROED ¿ NO CHANGE / SAME ERROR. NEUROSURGEON ON CALL IS CONTACTED AGAIN, AND SHE COMES TO THE ICU AND A NEW MICROSENSOR IS IMPLANTED. CONNECTED TO A NEW ICP EXPRESS AND CABLE (NOT USED BEFORE). 02:50 FIRST VALUE REGISTERED IN PICIS =7 MMHG WHICH ACCORDING TO NURSE IN CHARGE IS CONSIDERED TO BE A CORRECT VALUE DUE TO THE DRAINAGE OF LIQUOR DURING THE IMPLANTATION. THE ICP-VALUE SLOWLY INCREASE AND IN THE MORNING IT´S MORE ¿NORMAL¿ 15MMHG. (IT IS INTERPRETED AS LIQUOR HAS FILLED UP AGAIN). ICP REGISTERED IN PICIS: KL 04:00=10, 05:00=13, 06:00=16, 07:00=19, 08:00=15 MMHG. THIS MICROSENSOR (IMPLANTED (B)(6), 13:25) HAS BEEN SENT TO CODMAN, DEPUY SYNTHES. (COMMENT FROM DPS REP.: CASE (B)(4). ZERO REFERENCE NUMBER: 507. THIS MICROSENSOR AND ICP EXPRESS UNIT STILL WORKS (16/5). AFTER SHIFT END, NIGHT (B)(6). OP-PERSONNEL WRITES A POST-IT TO HEAD NURSE AT THE NEUROSURGERY DEPARTMENT. ¿THERE ARE NO MORE MICROSENSOR OP-SETS!! WE HAVE REOPERATED SEVERAL CODMAN TONIGHT! WE DON´T KNOW IF IT IS THE ICP EXPRESS OR THE MICROSENSOR THAT SHOWS WRONG? THEY GO MAD AND DO NOT WORK. /REGARDS OP-NURSE AND SURGEON¿ THESE UNITS (5ST) ARE SENT TO MEDICAL ENGINEERS DEPARTMENT AT THE HOSPITAL. NO TECHNICAL ERRORS ARE IDENTIFIED. (B)(6) CUSTOMER REPORTED: THE FIVE ICP EXPRESS UNITS MENTIONED IN THE TEXT HAS NOT BEEN SENT TO YOU. THEY WERE CHECKED BY THE ENGINEERS AT THE HOSPITAL WITH THE RESULT ¿NO TECHNICAL ERRORS ARE IDENTIFIED¿. THE PRODUCT RELATED TO THE REPORT IS THE MICROSENSOR, WHICH HAS BEEN SENT TO YOU TOGETHER WITH THE REPORT. (B)(6): RESPONSE FROM CUSTOMER REGARDING NUMBER OF CABLES/ICP EXPRESS BOXES: (B)(4). HOW MANY ICP EXPRESS UNITS IN TOTAL WERE USED ON THIS PATIENT? ANSWER: DUE TO MY COUNTING, 5 UNITS IN TOTAL. UNIT NR 5 WAS USED AFTER THE SECOND IMPLANTATION AND WAS STILL IN USE WHEN THE REPORT WAS WRITTEN. HOW MANY CABLES IN TOTAL WERE USED ON THIS PATIENT? ANSWER: 5 CABLES. THERE IS NO INFORMATION IN THE REPORT OF THESE UNITS BEING CLEARED BY THE TECHNICIANS. I WILL EMAIL MY CONTACT AT THE HOSPITAL TO GET CONFIRMATION ABOUT THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368362 NEUROMONITOR BASIC KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF CRCCKJ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention 82-6634| 82-6636