Catalog Number VASCULAR UNKNOWN |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)
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Event Date 01/05/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Mw5067684.(b)(4).The product code, lot# and facility name not provided on the medwatch.Therefore, no additional information is available at this time.If any additional information is provided at a later date the complaint information will be updated accordingly.
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Event Description
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Medwatch# mw5067684 received.The medwatch provides the following information: the patient was brought to the operating room for a heart transplant, induced and intubated.The 9fr double lumen cordis was placed in the right femoral vein.Betadine prep was used (patient with prior history of chlorhexidine allergy).After placement, hemodynamically unstable, hypotension, tachycardia and was treated for anaphylaxis.Cpr initiated.Rash noted on chest.Alternative central line placed.The catheter in question was removed.The procedure was cancelled and transplant successfully performed at a later date.
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Manufacturer Narrative
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Qn#(b)(4).Medwatch# - mw5067684.The reported complaint of an allergic reaction where a double lumen 9fr catheter was in use could not be confirmed without a sample and further information.A review of the device history records could not be performed since the product code, lot number, and facility name was not provided on the medwatch report.The probable cause of this event could not be determined based upon the information provided and without a sample.
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Event Description
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Medwatch# mw5067684 received.The medwatch provides the following information: the patient was brought to the operating room for a heart transplant, induced and intubated.The 9fr double lumen cordis was placed in the right femoral vein.Betadine prep was used (patient with prior history of chlorhexidine allergy).After placement, hemodynamically unstable, hypotension, tachycardia and was treated for anaphylaxis.Cpr initiated.Rash noted on chest.Alternative central line placed.The catheter in question was removed.The procedure was cancelled and transplant successfully performed at a later date.
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Search Alerts/Recalls
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