Model Number 2426-0007 |
Device Problem
Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set over-infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: #1 it was reported by the customer that the bag emptied was far greater then it was programed for.Verbatim: this is the 2nd occurance i have been made aware of. the secondary iv tubing is backing up into the primary bag and not being delivered to the patient. all iv tubing is set up correctly, with primary hung from the extension hook, so that fluid is pulled from the highest bag first (secondary). the first time it was only discovered because the rate that the secondary emptied was far greater then it was programed for.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set over-infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: #1 it was reported by the customer that the bag emptied was far greater then it was programed for.Verbatim: this is the 2nd occurence i have been made aware of.The secondary iv tubing is backing up into the primary bag and not being delivered to the patient.All iv tubing is set up correctly, with primary hung from the extension hook, so that fluid is pulled from the highest bag first (secondary).The first time it was only discovered because the rate that the secondary emptied was far greater then it was programed for.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-sep-2022.H6: investigation summary : one sample model ms3500-15 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.No additional testing was conducted as no primary set was returned.The root cause could not be determined because the primary set was not returned.A device history record review could not be performed because a lot number was not provided by the customer.
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Search Alerts/Recalls
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