Catalog Number UNKNOWN |
Device Problems
Inappropriate Audible Prompt/Feedback (2280); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that unspecified bd¿ syringe pump alarm went off.The following information was provided by the initial reporter: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.Verbatim: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.An infant received lipids at 1.4 ml/hr.30 ml syringe was hung at about 0500 on 2/23.Syringe alarm near empty at about 0930.Volume available displayed 2 ml but about 20 ml actual in syringe.Nurse removed and replaced syringe and correct available volume than displayed.After reviewing logs, it appears that the syringe module identified the syringe as a 30 ml bd with only 6.2982.There was no harm or adverse effect on the patient.
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Manufacturer Narrative
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The following fields have been updated with additional information: g.4.Date received by manufacturer: 2021-03-09.H.6.Investigation summary: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.
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Event Description
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It was reported that unspecified bd¿ syringe pump alarm went off.The following information was provided by the initial reporter: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.Verbatim: it was reported that the syringe pump with lipids displayed incorrect available volume than what was actually in the syringe.An infant received lipids at 1.4 ml/hr.30 ml syringe was hung at about 0500 on 2/23.Syringe alarm near empty at about 0930.Volume available displayed 2 ml but about 20 ml actual in syringe.Nurse removed and replaced syringe and correct available volume than displayed.After reviewing logs, it appears that the syringe module identified the syringe as a 30 ml bd with only 6.2982.There was no harm or adverse effect on the patient.
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Search Alerts/Recalls
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