ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE® CLEAR, CLAMP, ROTATING LUER; STOPCOCK, IV SET
|
Back to Search Results |
|
Catalog Number MC9013 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problems
Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 07/21/2023 |
Event Type
malfunction
|
Event Description
|
The event involved a 14" ext set w/0.2 micron filter, clave¿ clear, clamp, rotating luer where it was reported that when the patient got up to go to the washroom, she noticed the iv line was disconnected from the filter line while paclitaxel was infusing.The medication spilled on patient's hands, the rn¿s hands, and on the floor.The pump stopped and was cleaned using a chemotherapy spill kit and according to alberta health service (ahs) policy.The patient came into direct contact with cytotoxic drug and infusion was delayed while spill was cleaned up impact of the incident.Invasive procedure is not provided or not applicable.Additionally, it was reported that the filter tubing was completely disconnected from the iv tubing when the staff noticed it.It is unknown how long into infusion the leak occurred.No report of a blood loss or bleed back.There was patient involvement and no apparent harm-reached patient/person, inconvenient.
|
|
Manufacturer Narrative
|
The complaint of disconnection / loose connection on item mc9013 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot was reviewed and no non conformities were found that would have led the reported complaint.Additional contact: (b)(4).
|
|
Search Alerts/Recalls
|
|
|