Model Number 2420-0007 |
Device Problems
Material Separation (1562); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22015160; medical device expiration date: 01-jan-2020; device manufacture date: 22-dec-2021.Medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.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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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced component separation and disconnection difficulties.The following information was provided by the initial reporter: iv tubing spike broke off while trying to puncture a new bag of iv fluids.Having difficulties and trouble with disconnecting iv tubing from peripheral locks.They also have been having difficulty with iv tubing disconnection and inner portion of connection in iv tubing breaking has happened to them as well.
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Manufacturer Narrative
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Investigation summary no photo or sample was received for the customer's complaint of leakage.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model 2420-0007 lot number 22015160 was performed.The search showed that a total of 84,403 units in 1 lot number was built on 20jan2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced component separation and disconnection difficulties.The following information was provided by the initial reporter: iv tubing spike broke off while trying to puncture a new bag of iv fluids.Having difficulties and trouble with disconnecting iv tubing from peripheral locks.They also have been having difficulty with iv tubing disconnection and inner portion of connection in iv tubing breaking has happened to them as well.
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Search Alerts/Recalls
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