ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 19" (48 CM) EXT SET W/FLOW CONTROLLER, MICROCLAVE® CLEAR, CLAMP, ROTATING LUER,; PRIMARY IV SET
|
Back to Search Results |
|
Model Number MRSFC-19 |
Device Problem
Inaccurate Flow Rate (1249)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device is available for evaluation- it has not been received.E1 - initial reporter phone has an extension number of (b)(6).
|
|
Event Description
|
The event occurred on an unknown date involving a 19" (48 cm) ext set w/flow controller, microclave¿ clear, clamp, rotating luer, approx priming volume: 2.5 ml where it was reported that the end user claimed the flow rate is ~66% off and the controller does not accurately control the flow rate.The device was used in treatment or patient care.There was patient involvement but no human harm.No additional information was provided.
|
|
Manufacturer Narrative
|
Additional information: d9 - device available for evaluation and h3 - evaluation summary attached the complaint of difficult to control flow rate on item mrsfc-19 could not be confirmed by investigation.Since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history report (dhr) for lot 5633236 was reviewed and no non conformities were found that would have led to the reported complaint.
|
|
Search Alerts/Recalls
|
|
|