title: Relationship between drain volume/fill volume ratio and clinical outcomes associated with overfill complaints in peritoneal dialysis patients.
abstract: 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).
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Baxter Healthcare Corporation, McGaw Park, Illinois, USA. ira_davis@baxter.com
authors.forename: Ira D
authors.initials: ID
authors.lastname: Davis
authors.forename: Borut
authors.initials: B
authors.lastname: Cizman
authors.forename: Kelly
authors.initials: K
authors.lastname: Mundt
authors.forename: Lieling
authors.initials: L
authors.lastname: Wu
authors.forename: Robert
authors.initials: R
authors.lastname: Childers
authors.forename: Rod
authors.initials: R
authors.lastname: Mell
authors.forename: Sarah
authors.initials: S
authors.lastname: Prichard
mesh_terms: D015314:Dialysis Solutions / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004322:Drainage; D006801:Humans; D015994:Incidence; D010349:Patient Compliance; D010529:Peritoneal Cavity / Q000503:physiopathology*; D010530:Peritoneal Dialysis / Q000009:adverse effects* / Q000379:methods / Q000401:mortality; D010538:Peritonitis / Q000453:epidemiology / Q000209:etiology* / Q000503:physiopathology; D015996:Survival Rate; D017211:Treatment Failure; D014481:United States / Q000453:epidemiology
chemical_list: D015314:Dialysis Solutions