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Model Number 8888145044CP |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, the line was accessed and 5ml was initially withdrawn (no air bubbles was observed) and device was then flushed with saline pre heplock but on the first minute of treatment, some air bubbles was observed in the line and they had to withdraw fluid approximately three times due to the observed bubbles.It was stated that their initial thought was that the line was not secured adequately so the treatment was stopped, and a leak was noted on the luer adapter, line was then reconnected and the treatment restarted.No more air bubbles was seen during the 1 hour treatment with blood withdrawal/return at approximately 30ml/minute.It was stated that the patient was treated a week prior and no leak was noted on the line.Catheter was not repaired.There were no any patient symptoms or complications associated with this event.There was no reported patient injury.
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Manufacturer Narrative
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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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Event Description
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According to the reporter, the line was accessed and 5ml was initially withdrawn (no air bubbles was observed) and device was then flushed with saline pre heplock but on the first minute of treatment, some air bubbles was observed in the line and they had to withdraw fluid approximately three times due to the observed bubbles.Their initial thought was that the line was not secured adequately so the treatment was stopped, and a leak was noted on the luer adapter, line was then reconnected and the treatment restarted.No more air bubbles was seen during the 1 hour treatment with blood withdrawal/return at approximately 30ml/minute.The line was repaired without success and subsequently removed.It was stated that the patient was treated a week prior and no leak was noted on the line.Catheter was not repaired.There were no any patient symptoms or complications associated with this event.There was no reported patient injury.
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Search Alerts/Recalls
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