Gibt es hier auch jemanden der von dem Rückruf betroffen ist??
FDA Classifies Baxters January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action as a Class I Recall
Baxter is Deploying Revised Labeling, Training and Upcoming Software Revisions to Further Assist Clinicians and Patients
Baxter Press Release - March 2, 2010
Distribution Worldwide Distribution -- United States, Austria, Australia, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingdom and Venezuela
DEERFIELD, Ill. – Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter’s recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall. This action has been classified as a Class I recall because of the risk of serious injury or patient death that could be associated with the use of this device. Over the last two years, Baxter has received serious injury reports and at least one patient death report associated with this issue.
Baxter is continuing to investigate the causes, fixes, and mitigations associated with IIPV and use of the HomeChoice device. Current mitigations under development and implementation include changes to device labeling and software, which are intended to address issues such as prescription and patient errors, including bypassing alarms. Patients will receive new Patient At-Home Guides, which contain expanded information about IIPV, the symptoms, warnings and cautions, and how to address IIPV, should it occur. Baxter has also developed and is validating a software modification to address this issue and plans to submit a 510(k) to the FDA midyear. The software update will include additional user interface messages and alarms, and change default settings and allowable ranges to reduce risk of excessive accumulation of fluid in the peritoneal cavity.
USA FDA: Medical Device Class 1 Recall: Baxters HomeChoice Automated Peritoneal Dialysis Systems
FDA Medical Device Recalls - Last Updated: 03/02/2010
Product Baxter HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, and T5C4441R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.
Code Information All serial numbers.
Recalling Firm/Manufacturer Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park, Illinois 60085-6730
Reason for Recall Potential overfill of the peritoneal cavity, also referred to as Increased Intraperitoneal Volume (IIPV). IIPV can result in serious injury or death.
Action Urgent Product Recall letters dated January 8, 2010 were mailed to all Peritoneal Dialysis Clinicians on January 8, 2010 and letters dated January 12, 2010 to all Home Care Coordinators and Home Dialysis Patients on January 12, 2010, informing them of steps to take to help reduce or eliminate overfill, also referred to as Increased Intraperitoneal Volume, associated with HomeChoice/Homechoice Pro cyclers. Baxter Healthcare Corporation explained that they had received complaints of IIPV. The accounts were requested to complete and return the enclosed response form, indicating that they received and understood the notification, and if they still had a HomeChoice System or not. Any questions from the Home Care Coordinators are to be directed to the Baxter Global Technical Services at 1-800-553-6898.
Quantity in Commerce 61,398 units
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