COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING
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Model Number DIALYSIS UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
Peritonitis (2252)
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Event Type
Injury
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Manufacturer Narrative
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Title acute peritoneal dialysis in the newborn period: a 7-year single-center experience at tertiary neonatal intensive care unit in turkey source am j perinatol, volume 31, 2014 (335-338) date of publication: 28 june 2013.If information is provided in the future, a supplemental report will be issued.(b)(4).
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Event Description
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According to literature source of study performed between 2005 and 2011, pd (peritoneal dialysis) catheters were placed in 77 neonates.52.2% of patients had hyperglycemia, 19.4% of patients had leakage from catheter entrance, 14.9% of patients had peritonitis, 4.5% of patients had catheter obstruction, 4.5% of patients had bleeding when inserting the catheter, 3% of patient had catheter exit site infection, and 1.5% of patient had bowel perforation.The catheters used neonatal straight or pigtail single cuff catheter.Of patients who had peritonitis, two patients required removal of catheter and two patients with fungal peritonitis responded to removal of the peritoneal catheter and a 3-week course of intravenous amphotericin.Acute peritoneal dialysis and neonatal intensive care unit: nilay hakan, md, 2012, 2013, june 28.
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Manufacturer Narrative
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Correction: g4 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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