Catalog Number 37262E |
Device Problem
Backflow (1064)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that alaris smartsite extension set had blood backflow.The following information was received by the initial reporter with the verbatim: iv tubing started leaking while infusing ivf.Blood baked up on the line and caused a clot.Iv had to be replaced.Defective tubing replaced.Srs completed.
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Manufacturer Narrative
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E1: initial reporter facility name- (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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Pr 9211575 - follow up mdr for additional information (see b5) and device evaluation.No product or photo was returned by the customer.The customer complaint of leakage and blood backing up the line could not be verified due to the product not being returned for failure investigation.Device history record review for model 37262e lot number 23069391 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05jul2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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Event Description
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Additional information: customer response: the lot number provided by nursing was 1023069391 perhaps (10) 23069391.Unfortunately, the packaging was thrown away by nursing.They also did not provide a description of the damage/harm done to patient.Only one piece of tubing was affected.Just looking through the biohazard bag that the product is in, i cannot see any damage.I also don't have that information on the patient.Sorry i don't have any more information.
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Search Alerts/Recalls
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