As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
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This report summarizes one malfunction.A review of the reported information indicated that model a710962 apheresis port allegedly experienced restricted flow rate, failure to infuse, and port rotation.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.
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H10: as the lot number for the devices were not provided, a manufacturing review could not be performed.The devices were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.Gray, k.L., steidley, i.G., benson, h.L., pearce, c.L., bachman, a.M., & adamski, j.(2019).Implementation and 2-year outcomes of the first fda-approved implantable apheresis vascular access device.Transfusion, 59(11):3461-3467.Doi: 10.1111/trf.15512.H10: g3.H11: b5, g1, h6(conclusion).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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This report summarizes five malfunctions.A review of the reported information indicated that model a710962 apheresis port allegedly experienced restricted flow rate, failure to infuse, and port rotation.This information was received from one source.The malfunctions involved patients with no consequences.The patient's age, weight and gender were not provided.
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