Model Number NOT APPLICABLE |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f316 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f316 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #1: air detected.No trends were detected for each complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(6).
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Event Description
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The customer called to report a tubing leak during the treatment procedure.The customer stated the line lure lock on the patient's collect line would not seat properly, resulting in air being pulled into the line.The customer stated they noticed blood was leaking at the collect line connection site.The customer stated they received an air detected alarm at the start of the procedure which prompted them to check the connection, noting air in the collect line and the blood leak.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable.The customer did not return product for investigation.
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Manufacturer Narrative
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Correction: manufacturing site address revised.Device available for evaluation? yes.The kit segments of the collect and anticoagulant tubing lines, and collect line luer were returned for investigation.The smartcard was not returned therefore no alarms could be verified.The returned kit components showed evidence of blood indicating they had been used.The returned component assembly was cleaned and pressure tested using a syringe to apply pressure to the collect line luer while clamping off the patient access line.Pressure was applied and the lines were held under water.No leaks were identified.A material trace of the components used to build kit lot f316 found no related nonconformances.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.The reported tubing leak could not be verified or replicated during the investigation, therefore no root cause could be determined.This investigation is now complete.(b)(4).
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Search Alerts/Recalls
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