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It was reported that the hub of a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter was leaking.The line was inserted into the patient's subclavian vein in another facility before the patient was transferred to the provider that initiated the complaint.The line was used for administration of inotropes, fluids, and sedation treatments.It was reported that "while attending to [the] patient, it was observed [that the] patient was requiring significantly increased amounts of inotrope support running through mid lumen (blue hub)" of the device.The patient's treatment was altered as necessary as the infusions were transferred to other access ports until the patient stabilized and no longer required "excessive interventions".Additional information regarding the device has been requested but is unavailable at this time.No other adverse effects have been reported for this incident.
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Blank fields on this form indicate the information is unknown, unchanged or unavailable.Additional information: product identifier, d1, d4 - rpn.D1- device name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.Investigation evaluation.It was reported that a cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set (c-utlm-701j-rsc-abrm-hc-rd) from an unknown lot leaked at the blue hub.It is unknown how long the device was in place before the leakage was noted.Cook became aware of this event on 13feb2020 upon being notified by the clinical products advisor from waikato hospital.The patient reportedly experienced no adverse effects as a result of this incident.A review of documentation including the complaint history, instructions for use (ifu) and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.One used 7fr 20cm triple-lumen central venous catheter was returned for evaluation.Biological matter was found to be present throughout the device.The blue hub is cracked through the number ¿2¿ stamped on the hub.A leak test was performed and confirmed leakage at the blue hub.Non-cook needleless connectors were attached to the red and white hubs.The connector could not be removed from the red hub.The connector was removed from the white hub and the lumen was flushed with no incident.Additionally, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.A review of the device history record could not be completed due to lack of lot information from the user facility.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: warnings.The safe and effective use of central venous catheters with power injector pressures (safety cut-off) set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit of 10 ml/sec.To safely use catheters with a power injector, the technician/healthcare professional must verify prior to use that the maximum safety cut-off pressure limit is set at or below 325 psi and that the maximum flow rate is at or below 10 ml/sec.Power injection procedure.Warning: failure to ensure patency of the catheter lumen prior to injection may result in catheter failure.How supplied.Upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, examination of the returned product and the results of our investigation, a definitive root cause could not be established.A capa is currently open to address the issue of cracked hubs in this product line.The appropriate personnel have been notified.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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