MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; PUMP, INFUSION

Device Problems No Flow (2991); Protective Measures Problem (3015)

Patient Problem Hyperglycemia (1905)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

Patient had a dextrose 10% (d10) medication running through a left-arm peripheral iv (piv) at 5.7 ml/hr per orders.D10 fluids started.After discussing with neonatal nurse practitioner (nnp), another accu-check would be obtained 1.5 hrs later.Once fluids strung, fluid level in bag above the "50" line.Previous accu-checks before iv fluids had been stable at 64 and 45.When accu-check obtained, it read "high".This rn rechecked, and it again said "high".Nnp's called and ordered to try second accu-check machine, which also read "high" a few minutes later.Iv fluids immediately stopped and entire iv pump system turned off.Nnps at the bedside.Serum glucose obtained immediately and sent to lab at approximately 10 minutes later.D10 bag was at the "150" line on the bag at this time.This nurse had to run extra fluid through the tubing when stringing lines in order to clear air bubbles, but not enough that the fluid would be at the "150" line at this time.After iv pump system turned off, fluid was still seen dripping into reservoir chamber below where bag is spiked, and the fluid level was slightly below the "150" line on the bag.Both roller and tri-set port clamped, and iv tubing removed from patient.Piv saline locked.Nnp at bedside for this.Diapers weighed from 2nd care visit.The patient urinated during the diaper change so two diapers were used.The first diaper weighed 14g and the second weighed 30g.Nnps updated on this.20 minutes later, lab results were still not input in powerchart.Called lab again regarding this.Lab results called to nicu and called to nnp.Serum glucose was critical at 971.Patient's vitals stable and monitoring and rn at bedside.Mother updated in her mother-infant unit room by nnps.Approximately 10 minutes later, serum glucose and electrolytes drawn per nnp and sent to lab.Diaper changed at this time and weighed 15g.Critical sodium of 128 and critical glucose of 645 called to nicu from lab.These results were called to nnp.Patient's vitals and status stable.This rn at bedside and monitoring.

• Brand Name: ALARIS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 10894030
• MDR Text Key: 217938594
• Report Number: 10894030
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 11/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA