MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

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.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 16981958
• MDR Text Key: 315737020
• Report Number: 2016493-2023-168126
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100 ALARIS LVP MODULE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male