|
Catalog Number 21-7220-24 |
Device Problems
Device Alarm System (1012); Failure to Infuse (2340)
|
Patient Problems
Hyperglycemia (1905); Nausea (1970); Weakness (2145)
|
Event Date 11/04/2018 |
Event Type
Injury
|
Event Description
|
Information was received indicating that insulin was not infusing through a smiths medical cleo® 90 infusion set after the site being changed 1-2 days prior.The patient states that they woke during the night, feeling weak and nausea's, with blood sugar level of 510 despite trying to correct the level for over an hour.The infusion set was changed out and a corrective bolus was re-administered, bringing blood glucose down.Reported that no occlusion alarm prior to changing the site.The patient recovered with no further adverse effects.
|
|
Manufacturer Narrative
|
Date of event: (b)(6) 2017.
|
|
Manufacturer Narrative
|
Five cleo sets were received.The returned samples were received in used conditions inside a plastic bag without their original packaging.The samples were visually inspected, at a distance of 12" to 24" and normal conditions of illumination.Visual inspection revealed the following.Three of the samples were received used and without abnormalities, one sample was received with the cannula detached, and one sample was received with the septum white pad removed.The samples were tested using an infusion set to replicate the failure mode.No occlusion was detected during the testing, the water passed through the all septums.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
|
|
Search Alerts/Recalls
|
|
|