| RELATIONSHIP BETWEEN DRAIN VOLUME/FILL VOLUME RATIO AND CLINICAL OUTCOMES ASSOCIATED WITH OVERFILL COMPLAINTS IN PERITONEAL DIALYSIS PATIENTS. | |
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MedLine Citation:
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PMID: 21282375 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND: To better understand the spectrum of overfill reports and their corresponding clinical severity and etiology, we conducted a review of overfill reports from the Manufacturer and User Facility Device Experience (MAUDE) database, which is within the Food and Drug Administration (FDA) Web site (www.fda.gov). Method: We searched the MAUDE database for events related to overfill reports between 1 January 1995 and 31 December 2008 and recorded drain volume (DV)/fill volume (FV), or DV/FV, and clinical symptoms and signs associated with the overfill report. RESULTS: Among 462 MAUDE reports with a possible overfill event, 440 reports (95.2%) with a confirmed overfill event contained sufficient information to ascertain the clinical severity of the event. The number of reports with a clinical severity rating of minor, moderate, major, or death was 331, 71, 28, and 10, respectively. The median (range) DV/FV for a subgroup of 292 reports with a clinical severity rating of minor, moderate, major, or death was 1.63 (1.06 - 4.29), 1.71 (1.08 - 5.87), 2.14(1.64 - 2.61), and 2.50 (2.28 - 3.33), respectively. Insufficient drain accounted for a majority of overfill reports. CONCLUSION: Our analysis of reports from the MAUDE database suggests an association between DV/FV and clinical severity of the reported overfill event, as well as significant patient-to-patient variability with respect to intraperitoneal volume tolerance. |
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Authors:
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Ira D Davis; Borut Cizman; Kelly Mundt; Lieling Wu; Robert Childers; Rod Mell; Sarah Prichard |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-1-31 |
Journal Detail:
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Title: Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis Volume: - ISSN: 0896-8608 ISO Abbreviation: - Publication Date: 2011 Jan |
Date Detail:
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Created Date: 2011-2-1 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8904033 Medline TA: Perit Dial Int Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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Renal Division, Baxter Healthcare Corporat, McGaw Park, United States. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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