BEUDAMED
    FDA Adverse Event Summary report: N

    COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP

    MDR report key: 1490101 · Received October 5, 2009

    Report

    Report Number
    6000001-2009-00985
    Date Received
    October 5, 2009
    Date of Event
    September 11, 2009
    Report Date
    September 11, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE VERSION IS 5.03.00, CATEGORIZED AS UNREMEDIATED.

    Additional Manufacturer Narrative · 1

    (B) (4) THERE IS A CAPA INVESTIGATION ASSOCIATED WITH THIS REPORT. (B) (4) IT WAS DISCOVERED IN SERVICE AT BAXTER THAT THERE WAS AN INTERMITTENT STOP KEY ON THE CHANNEL C PUMPHEAD MODULE KEYPAD. THE CHANNEL C PUMPHEAD MODULE KEYPAD WAS REPLACED.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS A DUPLICATE ASSOCIATED WITH THE 6000001-2009-00996 MEDWATCH. COMPLAINT WILL BE CLOSED AS A DUPLICATE COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE FOLLOW UP REPORT SUBMITTED WAS MISSING THE AWARE DATE. THE AWARE DATE FOR FOLLOW-UP #1 IS 04 NOVEMBER 2009.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED BAXTER TO ADVISE THAT A COLLEAGUE VOLUMETRIC INFUSION PUMP HAD SMOKE COMING FROM THE PUMP IN AN UNKNOWN PROCESS STEP. IT IS UNKNOWN IF THERE WAS AN ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    DURING SERVICE BY BAXTER, THE INFUSION PUMP WAS FOUND TO CONTAIN AN INTERMITTENT STOP KEY ON THE CHANNEL C PUMPHEAD MODULE KEYPAD. THERE IS NOT AN ADVERSE EVENT, PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TAKING INSULIN BASED ON AN UNKNOWN HIGH READING THEY RECEIVED ON THEIR FREESTYLE LITE METER. THE CUSTOMER REPORTED SHE DID NOT REMEMBER HER SYMPTOMS; HOWEVER, SHE DID STATE SHE EXPERIENCED A LOSS OF CONSCIOUSNESS. THE PARAMEDICS WERE CALLED AND THEY TREATED THE CUSTOMER WITH UNKNOWN INTRAVENOUS FLUIDS AND A GLUCOSE SHOT. THE CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY WHERE THEY WERE DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH A "GLUCOSE BUSTER". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    LITERATURE: ABEJON D, SAZ, J.M., LEY L, SANCHEZ M.R., DEL POZO, C. [SPINAL GRANULOMA IN A PT RECEIVING A SPINAL INFUSION OF MORPHINE AND CLONIDINE]. REV ESP ANESTESIOL REANIM. 2009; 56(6):380-4. SUMMARY: THIS ARTICLE PRESENTS A CLINICAL CASE OF A PT WHO DEVELOPED A CATHETER-TIP GRANULOMA THAT REQUIRED EMERGENCY SURGERY FOR RESOLUTIONS AFTER YRS OF INTRATHECAL TREATMENT. REPORTABLE EVENT: THE PT UNDERWENT A SUCCESSFUL TRIAL (> 80% PAIN RELIEF) WITH MORPHINE AND CLONIDINE AND WAS IMPLANTED WITH AN INTRATHECAL INFUSION SYSTEM. THE PT BEGAN TO LOSE EFFICACY AFTER THE FIRST YEAR OF TREATMENT REQUIRING COMBINATIONS OF DIFFERENT DRUGS IN THE SECOND YEAR INCLUDING CLONIDINE ALONE, CLONIDINE AND BUPIVACAINE, PETHIDINE ALONE, BACLOFEN ALONE, AND BACLOFEN AND MORPHINE WITH A SIGNIFICANT THERAPEUTIC RESPONSE (> 50%). DURING THE THIRD YEAR OF TREATMENT, THE DOSE OF MORPHINE AND CLONIDINE WAS PROGRESSIVELY INCREASED FROM THE INITIAL DOSES OF 3-6 MG/DAY MORPHINE AND 250-275 MCG/DAY CLONIDINE TO A MAXIMUM DOSE OF 34 MG/DAY MORPHINE AND 1271 MCG/DAY CLONIDINE WITHOUT THE DESIRED RESULTS. DURING THIS TWO-YEAR INTERVAL A ROUTINE FOLLOW-UP MRI OF THE SPINAL COLUMN REPORTED THE PRESENCE OF SPINAL CORD ALTERATIONS AT T2-T3 CONSISTING OF HEMORRHAGIC REMAINS RELATED TO THE PREVIOUSLY EXCISED CAVERNOUS ANGIOMA WITHOUT OTHER CHANGES WHEN COMPARED TO PREVIOUS MRI. AFTER SUCCESSIVE REVISION OF THE INTRATHECAL TREATMENT, SIX YRS AFTER IMPLANT, THE PT DEVELOPED PROGRESSIVE NEUROPATHIC PAIN SYMPTOMS IN THE UPPER LIMBS WITH ANOMALOUS NEUROLOGICAL EXAM. AN MRI WAS ENLARGED IN THE CERVICO-DORSAL AREA AND SHOWED THE PRESENCE OF AN INTRADURAL-EXTRAMEDULLARY LESION WITH A LARGE BASE OF IMPLANTATION IN THE POSTERIOR SPINAL DURA MATER AT THE T1-T2 LEVEL. THE LESION IMPINGED POSTERIORLY, DEFORMING THE SPINAL CORD WITHOUT ALTERING THE INTRAMEDULLARY SIGNAL DESTINY IN THE T2 SAGITTAL SEQUENCE, SUGGESTIVE OF MENINGIOMA. THE PT WAS REFERRED TO NEUROSURGERY. A DORSAL LAMINECTOMY CENTERING ON T2 WAS PERFORMED AND THE EXTRAMEDULLARY TUMOR THAT SURROUNDED THE TIP OF THE INTRATHECAL CATHETER HAD A MACROSCOPIC APPEARANCE CONSISTENT WITH GRANULOMA WAS EXCISED ALONG WITH TIP OF THE CATHETER. THE REST OF THE CATHETER WAS LEFT IMPLANTED. INTRAOPERATIVE HISTOPATHOLOGICAL STUDY SHOWED SPINDLE-CELL PROLIFERATION, HYPOCELLULARITY AND NO ATYPIA, WHICH WAS COMPATIBLE WITH GRANULOMATOUS GROWTH AROUND THE CATHETER TIP. A SUBSEQUENT HISTOPATHOLOGICAL STUDY REVEALED THE PRESENCE OF A DORSAL EPIDURAL MASS CONSISTING OF FRAGMENTS OF MUSCULOADIPOSE TISSUE THAT ENGULFED SMALL BONE FRAGMENTS, WITH EXTENSIVE FIBROSIS, AND WITH REACTIVE AND INFLAMMATORY CHANGES, BUT WITHOUT ANY MORPHOLOGICAL FINDINGS INDICATING MALIGNANCY. FOLLOWING SURGERY, THE DOSE OF INTRATHECAL DRUGS REMAINED STABLE AT 34 MG/DAY MORPHINE AND 1001.38 MCG/DAY CLONIDINE. THE PT PERSISTED IN UNDERLYING PAIN SYMPTOMS AND WAS IMPLANTED WITH A DEEP BRAIN STIMULATION SYSTEM. THE RESULTED IN A REDUCTION IN THE INTENSITY OF BASELINE PAIN WHICH LED TO PROGRESSIVE REDUCTION IN THE INTRATHECAL DRUGS DOSES TO 9 MG/DAY MORPHINE AND 265.40 MCG/DAY CLINIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE TRIPLE CHANNEL VOLUMETRIC INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1