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Device Problem
Inaccurate Flow Rate (1249)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/15/2021 |
Event Type
malfunction
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Event Description
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It was reported that the patient was placed on catheter cart (serial# (b)(4)) for fever control.Nurse then started therapy and the device alerted that it needed to be filled and the device started to prime, and therapy stopped.Patient temperature was 39.2c, water temperature was 6.8c, target temperature was 37c.Four large pads in place.The patient weighed (b)(6) and had a large abdominal pannus.The nurse was using hypothermia mode and did not want to use normothermia.Then walked through filling the device and reconnecting the arctic gel pads and holder behind the clear clamps and confirmed that the cooling target was set to 37c started therapy and flow rate stabilized at 1.6 l/min.The nurse stated that the pads need to be repositioned however the patient was too unstable to move and recommended to add a universal pad to the exposed abdomen for better coverage.
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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 patient was placed on catheter cart (serial# (b)(6) ) for fever control.Nurse then started therapy and the device alerted that it needed to be filled and the device started to prime, and therapy stopped.Patient temperature was 39.2c, water temperature was 6.8c, target temperature was 37c.Four large pads in place.The patient weighed 350lbs and had a large abdominal pannus.The nurse was using hypothermia mode and did not want to use normothermia.Then walked through filling the device and reconnecting the arctic gel pads and holder behind the clear clamps and confirmed that the cooling target was set to 37c started therapy and flow rate stabilized at 1.6 l/min.The nurse stated that the pads need to be repositioned however the patient was too unstable to move and recommended to add a universal pad to the exposed abdomen for better coverage.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned.It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "nip roller pressure regulator set too high".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: the product catalog number and lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f the information provided by bard 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 bard.H3 other text : the device was not returned.
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Search Alerts/Recalls
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