Catalog Number SN1520GC |
Device Problems
Burst Container or Vessel (1074); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Event Description
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The complaint event occurred on an unspecified date and involved a inf.-leitung ernährung 96h lichtschutz.It was reported that the integrated 0.2 m filters simply burst when medication is injected.The situation can be recognized by a sudden loss of pressure during injection and liquid is escaping from the filter.This situation does not affect the line.There was patient involvement; however there was no report of human harm.
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Manufacturer Narrative
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It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not yet been received.Without the returned device, a probable cause is unable to be determined.If additional information or if a device later becomes available, supplemental vigilance report(s) will be submitted at that time.
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Manufacturer Narrative
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The device history record (dhr) was reviewed and no non-conformities were found that would have led the reported condition on the complaint.
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Event Description
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Additional information was received by the customer on12apr2024.The customer reported that the event happened sometime during (b)(6) 2024.The medication involved was a glucose/amino acid mixture (parenteral nutrition) from the in-house pharmacy.The product was stored in the facility in its original box in a cupboard storage.No chemo was noted and there was no patient harm associated with the complaint/event.
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Search Alerts/Recalls
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