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U.S. Department of Health and Human Services

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BRAND NAME8MP EUGLY PUMP
AUTOSYRINGE DIV. BAXTER HEALTHCARE CORP.
198 LONDONDERRY TNPK
HOOKSETT NH 03104
ACCESS NUMBERM168210
PRODUCT CODEFRN
PANELGENERAL HOSPITAL
REPORT TYPESERIOUS INJURY
DATE FDA RECEIVED05/25/1989
DEVICE MODEL NUMBER3M8413
DEVICE CATALOGUE NUMBER3M8413
EVENT DESCRIPTION TYPEFINAL
EVENT DESCRIPTION
HOSPITALIZED FOR DIABETIC KETOACIDOSIS WITH A GLUCOSE OF 900 MG/DL. TREATED WITH IV INSULIN AND HYDRATION. ON ADMISSION, THE HEALTH CARE PROFESSIONAL NOTED BLOOD IN THE INFUSION SET AND WAS UNABLE TO PURGE THE LINE. THE USER STATED THE INFUSION SET WAS REINSERTED SEVERAL TIMES THE NIGHT BEFORE BECAUSE OF NEEDLE DISCOMFORT. THE INSERTION AREAS ARE LIMITED BECAUSE OF SCAR TISSUE FROM PREVIOUS SURGERIES. THE ADMITTING PHYSICIAN IS NOT FAMILIAR WITH PUMP USE AND EVALUATION REQUESTED AS A PRECAUTIONARY MEASURE. THIS IS THE SAME PT AS WAS REPORTED IN M168209.
CLOSEOUT TEXT
THIS REPORT WAS REVIEWED FOR SIGNIFICANT PROBLEMS BUT WAS NOT CLOSED. IT IS BEING CLOSED AT THIS TIME AS PART OF A BATCH CLOSEOUT PROCESS IN ORDER TO PREPARE THE DATABASE TO SERVE AS HISTORICAL SUPPORT TO A REDESIGNED DATABASE.
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