MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINSTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2123-0007

Device Problems Air Leak (1008); Excess Flow or Over-Infusion (1311)

Patient Problems Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914); Respiratory Acidosis (2482)

Event Date 05/01/2016

Event Type  malfunction  

Event Description

The following event is from two perspectives.The first perspective: upon initial assessment of the patient at approximately 0815, tpn bag was noted to be empty and there was air in the infusion set line.The tpn infusion was running at 4.6cc/hr on the alaris pump as reported.Immediately, i stopped the infusion and left the lipids to run into the uvc to prevent backflow of blood.Flex rn was called along with medical staff.Labs sent and initial glucose was critical value of 990, vs obtained.Electively intubated based on initial vbg for which she received morphine and ativan.Lower bp's followed and thought to be related to sedation for which she received 0.9 ns bolus x2.Hourly glucose monitoring occurred and d10w.45 with heparin started once glucose in 200 range.They remained appropriate and have been checked with gases.Vs since normalized.Baby has been responsive, moves all extremities (mae's), active with cares; vent weans made following 1700 vbg.Parents updated fully, asking lots of questions.Risk management notified via charge rn.Alaris pump left running until picked up by engineering.The second perspective: premature infant, who was admitted/born at 856pm and admitted to the neonatal intensive care unit for management of prematurity in the setting of preterm premature rupture of the membranes (pprom) and chorioamnionitis.The morning of this event, tpn was found to have infused at > 2x desired rate.Stat vbg, complete metabolic panel (cmp), mag, and phos obtained.Vbg showed 7.037/83.6/32.9, sodium 137, potassium 5.1, calcium 1.71, and lactate 7.6.Given respiratory acidosis she was intubated.

• Brand Name: ALARIS PUMP MODULE ADMINSTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 5849561
• MDR Text Key: 51261909
• Report Number: 5849561
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2016,07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2123-0007
• Other Device ID Number: 2 Y-SITE 102IN DEHPFREE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other