Catalog Number SSRK1008 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the wires of sensica device power cord were exposed.Per there were 3 power cords given by the nursing staff from the unit where they witnessed sparks coming from the power cord.The exposed copper was found consistent in all 3 sets of cords.Customer would send us the incident reports so that we have dates on file in which these incidents occurred.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be user related due to inadequate securement of power cord to system.However, this cannot be confirmed.The device was returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: the power cord assembly for the bd sensica¿ urine output system plugs into the base of the stand.The cable tie is provided for convenience in keeping the power cord attached to the system.The tie is connected to the power plug at the plug end.Additional slots in the cable tie allows the cable to be used to tie the entire power cord assembly to the system stand.The actual/suspected device was inspected.
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Event Description
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It was reported that the 3 power cords of sensica device¿s power cord were exposed.Nursing staff witnessed sparks coming from those 3 power cords while in operation in the intensive care unit (icu).The exposed copper was found consistent in all 3 sets of cords.Customer would send us the incident reports so that we have dates on file in which these incidents occurred.Per follow up information received on 29jul2022, nurse stated the serial numbers were not available for any of the sensica devices as the power cords were removed at the time of failure and replaced with functioning cords.The cords have been sent to bd.All three events involved patients as the device had to be disconnected from power at the point of care while a new power cord was obtained.Only one cord sparked (this was physically marked with a sticky note).There were no patient injuries.
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Search Alerts/Recalls
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