ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 128" (325 CM) APPX 16.5 ML, 15 DROP PRIMARY SET W/2 MICROCLAVE®, REMV 2 GANG 4-W; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number B90019 |
Device Problem
No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned for evaluation; however, testing has not yet been completed.E1 additional initial reporter phone number: (b)(6).
|
|
Event Description
|
The event occurred on an unspecified date and involved a 128" (325 cm) appx 16.6 ml, 15 drop primary set w/2 microclave¿, remv 2 gang 4-way clave¿ stopcock, rotating luer, 2 ext where it was reported a registered nurse primed the set and the fluid could be seen at the end of the tubing and in the distal chamber.When the device was connected to the patient's iv, blood backed out into the tubing and would not run.The customer stated the iv flushed great at the closest port to the patient.It would not flow to gravity.They had to remove the tubing and place a new set up which worked for the case.There was patient involvement, however no patient harm reported.
|
|
Manufacturer Narrative
|
Received: one (1) used.List #b90019, 128" (325 cm) appx 16.6 ml, 15 drop primary set w/2 microclave¿, remv 2 gang 4-way clave¿ stopcock, rotating luer, 2 ext; lot #13598628.The reported complaint of back flow and no flow at gravity was not confirmed.No visual anomalies were observed on the returned set.The check valve resistance of the sample was tested, according to customer drawing specification from the distal end, to test the check valve, and no backflow was confirmed after the test.The set was primed to gravity pressure and a normal flow was observed through the device.No occlusion or anomalies were observed.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|