Reducing the Risk of Overfill with HomeChoice Peritoneal Dialysis


Uploaded by USFoodandDrugAdmin on 21.05.2010

Transcript:
>> Barnett: HERE'S AN ALERT ABOUT THE RISK OF OVERFILL IN
PATIENTS BEING TREATED WITH BAXTER'S HomeChoice AND
HomeChoice PRO AUTOMATED PERITONEAL DIALYSIS SYSTEMS.
OVERFILL, OR INCREASED INTRAPERITONEAL VOLUME, OCCURS
WHEN THERE'S MORE FLUID IN THE ABDOMEN THAN WAS PRESCRIBED.
THIS MAY RESULT IN SERIOUS INJURY OR DEATH FROM A NUMBER OF
CONDITIONS, INCLUDING ABDOMINAL WALL OR DIAPHRAGMATIC HERNIAS,
HYDROTHORAX, HEART FAILURE, ACUTE HYPERTENSION,
PULMONARY EDEMA, DECREASED PULMONARY FUNCTION,
PERICARDIAL EFFUSION, AND PERITONITIS.
>> OVER THE LAST TWO YEARS, BAXTER HAS RECEIVED REPORTS OF
SERIOUS INJURIES AND AT LEAST ONE DEATH ASSOCIATED
WITH OVERFILL.
CHILDREN MAY BE MORE LIKELY TO EXPERIENCE THIS PROBLEM,
BECAUSE OF THEIR SMALLER SIZE.
CRITICALLY ILL PATIENTS AND THOSE WITH PULMONARY AND
HEMODYNAMIC INSTABILITY MAY ALSO HAVE A HIGHER RISK.
BAXTER ALERTED PATIENTS AND CLINICIANS TO THIS PROBLEM
IN A JANUARY LETTER.
>> ALTHOUGH BAXTER IS NOT REMOVING THE HomeChoice SYSTEMS
FROM THE MARKET, CLINICIANS SHOULD WEIGH THE
RISKS AND BENEFITS OF CONTINUING TO TREAT THEIR PATIENTS WITH
THESE DEVICES.
CLINICIANS SHOULD ALSO REVIEW THEIR PRESCRIPTION SETTINGS FOR
THE HomeChoice SYSTEMS.
>> PATIENTS AND CAREGIVERS SHOULD WATCH FOR POTENTIAL SIGNS
AND SYMPTOMS OF OVERFILL WHEN USING HomeChoice SYSTEMS.
THIS IS ESPECIALLY IMPORTANT FOR CHILDREN AND FOR PATIENTS WHO
ARE UNABLE TO COMMUNICATE.
IF SIGNS OF OVERFILL OCCUR, PATIENTS OR THEIR CAREGIVERS
SHOULD STOP THE DEVICE, START A MANUAL DRAIN, AND
CONTACT THEIR DOCTOR IMMEDIATELY.
>> Barnett: HERE ARE SOME OF THE SIGNS TO WATCH FOR --
DIFFICULTY BREATHING OR FEEDING; ABDOMINAL BLOATING,
TENSION, OR PAIN; AND LOCALIZED SWELLING AROUND
THE GROIN, THE GENITAL AREAS, OR THE BELLY BUTTON,
OR AROUND THE CATHETER'S TUNNEL TRACT OR EXIT SITE.
>> IN ADDITION, PATIENTS AND CAREGIVERS SHOULD
ASK THEIR DOCTORS ABOUT WHETHER THEY SHOULD MONITOR VITAL SIGNS,
SUCH AS HEART RATE, BLOOD PRESSURE, AND OXYGEN SATURATION.
THEY SHOULD ALSO ASK ABOUT WHETHER TO TRACK PRE- AND
POSTTREATMENT WEIGHT IN ORDER TO COMPARE THE DIFFERENCE IN
WEIGHT TO THE RECORDED ULTRAFILTRATION VOLUME
ON THE DEVICE.
>> Barnett: FOR MORE INFORMATION, CALL BAXTER AT
1-800-553-6898 OR GO TO OUR WEB SITE.