Device Problem
Biocompatibility (2886)
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Patient Problem
Burn(s) (1757)
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Event Date 10/29/2021 |
Event Type
Injury
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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 a pediatric patient had thermal injury to legs & upper body in the pediatric intensive care unit.User needed assistance with obtaining a list of alarms.Mss explained that the user could download case data that shows patient temperature, water temperature and other alarms.Mss discussed regarding extended cold and warm water alerts and instructed for a diligent skin check according to facility protocol.Mss emailed instructions for case download and list of alerts and alarms to the user.It was unknown what medical intervention was provided.
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Event Description
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It was reported that a pediatric patient had thermal injury to legs & upper body in the pediatric intensive care unit.User needed assistance with obtaining a list of alarms.Mss explained that the user could download case data that shows patient temperature, water temperature and other alarms.Mss discussed regarding extended cold and warm water alerts and instructed for a diligent skin check according to facility protocol.Mss emailed instructions for case download and list of alerts and alarms to the user.It was unknown what medical intervention was provided.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿materials that are contacting the patient¿s intact skin are not bio compatible ¿.It was unknown whether the device had met relevant specifications.The product was used for diagnostic purposes.It was unknown whether the product had caused the reported failure.The product catalog number and lot number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review and the device history record could not be reviewed h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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