SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
|
Back to Search Results |
|
Model Number 21-7345-24 |
Device Problems
Device Alarm System (1012); Failure to Deliver (2338); Obstruction of Flow (2423)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/06/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D5 is the patient/consumer.
|
|
Event Description
|
It was reported that the pump was counting down volume in milliliters, but the bag was completely full.Pump event log was also alarming downstream occlusions, "admin set latched" and the pump was not infusing.No patient injury was reported.
|
|
Manufacturer Narrative
|
Other, other text: h6: event problem and evaluation codes: updates not required.H10: no product was returned therefore, no visual or functional evaluation could be performed.Results: we are unable to confirm the reported complaint as no sample was received for investigation.Root cause of the reported event is unknown and cannot be determined as no sample was received.If the product is returned, the manufacturer will reopen this complaint for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
|
|
Search Alerts/Recalls
|
|
|