Model Number 2260-0500 |
Device Problems
Complete Blockage (1094); Inaccurate Flow Rate (1249)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/13/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Lot #: the batch number provided does not match the catalog number given.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported when using the as lvp 20d low sorb, the device experienced flow issues and over infusion.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that there overinfusion.I am emailing to report a potential over-infusion: event description: pump infused more mgso4 than it was programmed to.Patient effect: no harm reported.
|
|
Event Description
|
It was reported when using the as lvp 20d low sorb, the device experienced flow issues and over infusion.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that there overinfusion.I am emailing to report a potential over-infusion:.Event description: pump infused more mgso4 than it was programmed to.Patient effect: no harm reported.
|
|
Manufacturer Narrative
|
H6: investigation summary: no product or photo was returned by the customer.It was reported that there was an over-infusion.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2260-0500 because an invalid lot number was provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h10.
|
|
Search Alerts/Recalls
|