Catalog Number CS-45854-HP |
Device Problem
Insufficient Information (3190)
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Patient Problems
Anaphylactic Shock (1703); Erythema (1840); Itching Sensation (1943)
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Event Date 04/23/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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The customer reports: patient was going to operating theatres for a cardiac procedure.The patient had im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting sever itchy red skin over trunk, arms and legs.The patient became tachycardic and low-grade fever.Line was removed and anaphylaxis treatment response protocol was initiated, and procedure cancelled.Patient was transferred to icu where he remained for 24hrs.Symptoms resolved, and patient was discharged.Allergy testing is pending.The patient had no known allergies.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Event Description
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The customer reports: patient was going to operating theatres for a cardiac procedure.The patient had im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting sever itchy red skin over trunk, arms and legs.The patient became tachycardic and low-grade fever.Line was removed and anaphylaxis treatment response protocol was initiated, and procedure cancelled.Patient was transferred to icu where he remained for 24hrs.Symptoms resolved, and patient was discharged.Allergy testing is pending.The patient had no known allergies.
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Search Alerts/Recalls
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