Model Number 8100 |
Device Problems
Excess Flow or Over-Infusion (1311); Insufficient Information (3190)
|
Patient Problems
Anemia (1706); High Blood Pressure/ Hypertension (1908); Intra-Abdominal Hemorrhage (4479)
|
Event Date 03/01/2023 |
Event Type
Injury
|
Manufacturer Narrative
|
Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
|
|
Event Description
|
Received a copy of the customer's medwatch report from fda which states, ¿rn hung vasopressin in evening, cosigned at bedside with pharmacist.Approximately 45 minutes later rn noticed patient's bp was more elevated than expected, rechecked her lines/drips and recognized that the whole 100cc bottle had infused within 30-40 min when it was programmed to run in the smart pump at 9 ml/hr which would take closer to 10 hours to infuse a whole bottle.Patient had oozing of blood around abdominal wound vac.Unsure if elevated bp from event may have lead to increased bleeding.Hgb on labs done morning of event in early morning was 7.0.Repeat hemoglobin after 1 unit of prbc given was 6.5.Current vasopressin drip stopped; other vasopressors turned off.".
|
|
Event Description
|
Received a copy of the customer's medwatch report from fda which states, ¿rn hung vasopressin in evening, cosigned at bedside with pharmacist.Approximately 45 minutes later rn noticed patient's bp was more elevated than expected, rechecked her lines/drips and recognized that the whole 100cc bottle had infused within 30-40 min when it was programmed to run in the smart pump at 9 ml/hr which would take closer to 10 hours to infuse a whole bottle.Patient had oozing of blood around abdominal wound vac.Unsure if elevated bp from event may have lead to increased bleeding.Hgb on labs done morning of event in early morning was 7.0.Repeat hemoglobin after 1 unit of prbc given was 6.5.Current vasopressin drip stopped; other vasopressors turned off." refer to mfr report #2016493-2023-136615.
|
|
Manufacturer Narrative
|
Correction: describe event or problem.Additional information: imdrf annex a, g code and manufacturer narrative.Bd learned from the customer that the event reported under this mdr is the same event that was detailed in a previously submitted mdr mfr report#: 2016493-2023-136615).This supplemental report is submitted requesting to disregard mfr report#: 2016493-2023-168126 as it was deemed duplicate of mfr report#: 2016493-2023-136615.
|
|
Search Alerts/Recalls
|