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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Received one set of four used arcticgel pads only.Per visual evaluation, the pads were reviewed and the trim pattern was found to be correct, the energy connectors were found to be free of damages and a good connection was presented.No manufacturing issues related to the pads were noted during the visual evaluation.Per functional testing, the pads were 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 and the water immediately started flowing to the pads without any problems.Left chest pad: a total of 3.41 l/min m2 of flow rate were registered during the test due to the pad was noted crushed.Left thigh pad: a total of 1.91 l/min m2 of flow rate were registered during the test.Right chest pad: a total of 3.66 l/min m2 of flow rate were registered during the test.Right thigh pad: a total of 3.18 l/min m2 of flow rate were registered during the test.The flow rate was found to be unacceptable with the left thigh pad.The other pads were found acceptable; the flow rate for this product must be above 2.4 l/min m2.The complaint was confirmed as for the reported event as manufacturing related.The lot number is unknown; therefore, a device history record could not be reviewed.The instruction for use states the following: "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 fullpad 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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