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Device Problems
Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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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 nurse could not see the water passing through the pads.Per troubleshooting, the pads were disconnected and reconnected , but the issue persisted.The pads had to be switched.
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Manufacturer Narrative
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The reported event was inconclusive.It was unknown whether the device had met specifications.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be, "belt temperatures too low after nip roller and heated section." the lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, labeling review could not be performed.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.H3 other text : the device was not returned.
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Event Description
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It was reported that the nurse could not see the water passing through the pads.Per troubleshooting, the pads were disconnected and reconnected , but the issue persisted.The pads had to be switched.
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Search Alerts/Recalls
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