Model Number 50000000E |
Device Problems
Failure to Pump (1502); Pumping Problem (3016)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/02/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
|
|
Event Description
|
It was reported that biomed received data files showing that the mixing pump had failed.Biomed stated that they would order and replace the pump onsite.Per follow up information received on 05aug2022, there was no patient involvement reported.Biomed would repair the device onsite.
|
|
Manufacturer Narrative
|
The reported issue was confirmed.The device was not returned.The root cause of the reported issue was isolated to mixing pump failure.It is known that the device did not meet specifications and the device was influenced by the reported failure.There was no patient involvement.The device history record review was not required as reported issue was confirmed through other elements of the investigation to not be manufacturing related.The labeling review was not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
|
|
Event Description
|
It was reported that biomed received data files showing that the mixing pump had failed.Biomed stated that they would order and replace the pump onsite.Per follow up information received on 05aug2022, there was no patient involvement reported.Biomed would repair the device onsite.
|
|
Search Alerts/Recalls
|