Device Problems
Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
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.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.
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Event Description
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It was reported that the device produced an air leak alarm, and the flow was very low, which caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
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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.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.
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Event Description
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It was reported that the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
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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.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.
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Event Description
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It was reported that the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
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Manufacturer Narrative
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Received 1 used arcticgel pad kit.The visual inspection noted a crack in the connector of the left thigh pad.The other connectors were found with no deformities in the tip of energy connectors.No other obvious defects were observed.Per the functional evaluation, each pad was submitted to the flow rate test with the arctic sun machine model 2000.The pads were connected to the arctic sun machine model 2000 for 10 minutes, see details below: left chest pad: a total of 3.18 l/min m2 of flow rate were registered during the test.Left thigh pad: a total of 3.82 l/min m2 of flow rate were registered during the test.Right chest pad: the flow was never stabilized due to the energy connector was cracked causing air leakage.Right thigh pad: a total of 3.82 l/min m2 of flow rate were registered during the test.The flow rate of the right chest pad never was stabilized because the energy connector was damaged (deformed) causing air leakage.The flow rate was found to be acceptable for the others pads.The flow rate for this product must be above 2.4 l/min m2.The reported event was confirmed with an unknown cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "5.Attach the pad¿s line connectors to the patient line manifolds.Begin circulating water through the pads using either patient temperature control mode (automatic) or water temperature control mode (manual).If the pads fail to prime or a significant continuous air leak is observed in the pad return line, check connections, then if needed replace the leaking pad.¿ ¿6.Once the pads are primed, assure the flow rate displayed on the control panel is greater than 2.3 liters per minute, which is the minimum flow rate for a full pad kit.¿ (b)(4).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.
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Event Description
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It was reported that the device produced an air leak alarm, and the flow was very low, which allegedly caused therapy to abruptly stop.As a result, the pads were replaced with a new set of pads, and therapy was resumed with no further reported issues.The problem was noted after the pads were on the patient for 2 days.
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Search Alerts/Recalls
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