Document Detail


Relationship between drain volume/fill volume ratio and clinical outcomes associated with overfill complaints in peritoneal dialysis patients.
MedLine Citation:
PMID:  21282375     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Ira D Davis; Borut Cizman; Kelly Mundt; Lieling Wu; Robert Childers; Rod Mell; Sarah Prichard
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Publication Detail:
Type:  Journal Article; Review     Date:  2011-01-31
Journal Detail:
Title:  Peritoneal dialysis international : journal of the International Society for Peritoneal Dialysis     Volume:  31     ISSN:  1718-4304     ISO Abbreviation:  Perit Dial Int     Publication Date:    2011 Mar-Apr
Date Detail:
Created Date:  2011-03-23     Completed Date:  2012-01-03     Revised Date:  2012-08-08    
Medline Journal Info:
Nlm Unique ID:  8904033     Medline TA:  Perit Dial Int     Country:  Canada    
Other Details:
Languages:  eng     Pagination:  148-53     Citation Subset:  IM    
Affiliation:
Baxter Healthcare Corporation, McGaw Park, Illinois, USA. ira_davis@baxter.com
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MeSH Terms
Descriptor/Qualifier:
Dialysis Solutions / administration & dosage*
Dose-Response Relationship, Drug
Drainage*
Humans
Incidence
Patient Compliance*
Peritoneal Cavity / physiopathology*
Peritoneal Dialysis / adverse effects*,  methods,  mortality
Peritonitis / epidemiology,  etiology*,  physiopathology
Survival Rate
Treatment Failure
United States / epidemiology
Chemical
Reg. No./Substance:
0/Dialysis Solutions

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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