ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13" SMALLBORE QUADFUSE EXT SET W/3 MICROCLAVE® (GLOW, 2 RED RINGS), 0.2 MICRON F; STOPCOCK, I.V. SET
|
Back to Search Results |
|
Catalog Number B33902 |
Device Problems
Break (1069); Disconnection (1171); Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2023 |
Event Type
malfunction
|
Event Description
|
The event occurred on from late june through mid july and involved a 13" smallbore quadfuse ext set w/3 microclave® (glow, 2 red rings), 0.2 micron filter, 4 clamps, rotating luer, where it was reported that their nicu had experienced malfunctions in the last 3 weeks related to a broken filter.The stated issue was product disconnecting/falling apart.There was leaking and the defective product was infusing with fluid, total parenteral nutrition (tpn) and lipids.There were several patients involved, no patient harm but patients needed septic work ups, and there was delay in therapy as all tubing had to be changed delaying administration.This captures eighteen of twenty occurrences.
|
|
Manufacturer Narrative
|
It is unknown if the device is available for evaluation.The device has been requested to be returned, however, it has not been received.Without the returned device, a probable cause is unable to be determined.
|
|
Search Alerts/Recalls
|
|
|