ICU MEDICAL COSTA RICA LTD. PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 142730490 |
Device Problems
False Alarm (1013); No Flow (2991)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/09/2023 |
Event Type
malfunction
|
Event Description
|
The event involved an plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in where the customer reported that the device gave n185 alarm code during patient infusion.The customer stated that they tried 2 different plum a+ pumps and they were having same issue.The customer stated that there were no issues with the pumps as they worked fine with other sets.The solution being infused was normal saline.There were no obvious defects such as crack/break/cut/hole/tear noted on the tubing set.The tubing set was replaced and therapy resumed.The product was stored in the air-conditioned room in the hospital and was not exposed to extreme temperature.There was patient involvement but no patient harm.This is report two of six.
|
|
Manufacturer Narrative
|
The device has been returned for evaluation, however, investigation is not yet complete.E1 - additional contact information (b)(6).
|
|
Manufacturer Narrative
|
The used 140073190 plum burette set was received for inspection.No visual damages or anomalies noted.The set was attached to an icu medical provided iv bag, primed per packaging directions and a flow test was performed using an icu plum pump.There were no difficulties in priming, no cassette errors, no occlusion alarms or air in line alarms were generated and no restrictions in flow were observed.The reported complaint of a proximal occlusion alarm was unable to be replicated on the received sample.The complaint of n185 alarm can be confirmed based on lot history.The probable cause of the occlusion alarm is related to material variability in cassette diaphragm stiffness which could cause an increase in the frequency of proximal occlusion alarms, corrective actions are in process.
|
|
Search Alerts/Recalls
|
|
|