Model Number 21-7324-01 |
Device Problem
Inaccurate Delivery (2339)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/26/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Event Description
|
It was reported the disposable exhibited nothing or limited liquid was flowing through.Therefore, it had to be replaced at 2 weeks time.No adverse patient effects were reported by the customer.The first pipe which was attached to the patient was replaced and thrown away.The other 2 pipes which are available for investigation were attached to the pump but never reach the patient.
|
|
Manufacturer Narrative
|
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
|
|
Search Alerts/Recalls
|