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.
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: Alp Akonur; Catherine A Firanek; Mary E Gellens; Audrey M Hutchcraft; Pranay Kathuria; James A Sloand Journal: Perit Dial Int Date: 2015-08-20 Impact factor: 1.756
Authors: Borut Cižman; Steve Lindo; Brian Bilionis; Ira Davis; Aaron Brown; Jennifer Miller; Gerald Phillips; Alex Kriukov; James A Sloand Journal: Perit Dial Int Date: 2014-06 Impact factor: 1.756