ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CHEMOLOCK; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
|
Back to Search Results |
|
Model Number CL2000S |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problems
No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
|
Event Date 09/13/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has been returned for evaluation.Investigation is not complete.The lot number of the device that was in use is unknown.The customer identified seven possible lot numbers (plots).The possible lot numbers are 4876585 (expiry date 06/01/2025 , mfr date 06/01/2020), 4866111 (expiry date 06/01/2025, mfr date 06/01/2020), 4962243 (expiry date 08/01/2025, mfr date 08/01/2020).
|
|
Event Description
|
The event involved a chemolock when the nurse went to check on a patient to complete their assessment it was discovered a line unattached from the patient and cytarabine was infusing freely into the bed.The customer reported the chemolock cap was no longer attached to the iv line and was also no longer attached to the patient's quadfuse extension set, with the chemolock found in the bed.It was reported that the patient did not receive approximately 1 hour of chemotherapy from a 4 day continuous infusion of cytarabine, as they have to wait for a new bag to be made and send up and reprime the bag.There was patient involvement of an almost (b)(6) year old patient, and no adverse event was reported.
|
|
Manufacturer Narrative
|
H10 - a representative video was provided and evaluated.The video shows a single chemolock injector being manually connected to a chemolock port on a trifuse extension set and then pulled apart without pressing the release clips.No visible damage or anomalies can be seen in the video.Two list# cl2000s, chemolock injectors (lot# 4876585) were returned.One was received in an opened pouch and one was received in a sealed pouch.Each injector was visually inspected and no damage or anomalies were identified.Each cl2000s was manually connected to a chemolock port from icu medical inventory without issue.The two samples were then connected to the chemolock ports provided and were leak tested.No leaks or disconnections occurred.The reported complaint can be confirmed based on the video provided.Although the video shows the chemolock devices being separated, the release clips were not pressed.The dfu states: remove chemolock from the port by grasping and pressing the release clips.Additional follow up with the customer revealed the patients they saw this issue occur with were toddlers who have a tendency to move around and pull on the lines.Therefore, the probable cause is due to an unintentional excessive pulling force applied during use.The device history review for lot#'s 4876585, 4866111 and 4962243 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|