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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hyperglycemia (1905); Electrolyte Imbalance (2196)

Event Date 09/17/2021

Event Type  Injury  

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.A follow up report will be submitted once the failure investigation has been completed.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded of this mdr report.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.

Event Description

It was reported that a total parenteral nutrition (tpn) was hung and verified at 2045 by the rn.The pump was set to run at a rate of 4.5 ml/hr with volume to be infused of 108ml on a premature baby who was born at (b)(6).At 2145, the rn checked the patient's blood glucose, which was a critical value (greater than 500).The rn rechecked the blood glucose on a different glucometer, which yielded the same result.The provider was called to the bedside and at that point, the pump was stopped and the tpn bag was inspected.At this time, the tpn bag and the volutrol administration set were empty.The staff inspected the bed and surrounding area to ensure that was no leaking of the tpn fluids.The baby was re-weighed (daily weight was taken prior to start of tpn) and found to have gained 235 grams between 2045 and 2200, suggesting that the baby received the entire 24 hours' worth of infusion within 1 hour.Point of care blood result at 2225 showed metabolic acidosis: "7.1/54/-11, sodium 119, potassium 5.3, ionized calcium 1.15".Subsequent bloodwork results: sodium 117, potassium 5.4, chloride 88, carbon dioxide 15, blood urea nitrogen (bun) 21, glucose 1195, calcium 7.3, magnesium 2.8.Due to the event, the fluid was changed to normal saline at 60ml/kg/day and sodium acetate at 20ml/kg/day to correct the electrolyte imbalance and acidosis.Bun/creatinine continued to rise over the next few days.Hypoglycemia occurred at 0424 am with interventions deployed to correct the hypoglycemia.Bloodwork was trended and glucose levels were closely monitored until returned to baseline.The vital signs were monitored closely.It was also reported that the patient experienced increase gastric residuals and intermittent emesis, wherein hyperglycemia was followed by hypoglycemia.The patient had altered electrolytes for several days despite interventions to correct imbalances.

Event Description

It was reported that a total parenteral nutrition (tpn) was hung and verified at 2045 by the rn.The pump was set to run at a rate of 4.5 ml/hr with volume to be infused of 108ml on a premature baby who was born at 35 weeks.At 2145, the rn checked the patient's blood glucose, which was a critical value (greater than 500).The rn rechecked the blood glucose on a different glucometer, which yielded the same result.The provider was called to the bedside and at that point, the pump was stopped and the tpn bag was inspected.At this time, the tpn bag and the volutrol administration set were empty.The staff inspected the bed and surrounding area to ensure that was no leaking of the tpn fluids.The baby was re-weighed (daily weight was taken prior to start of tpn) and found to have gained 235 grams between 2045 and 2200, suggesting that the baby received the entire 24 hours' worth of infusion within 1 hour.Point of care blood result at 2225 showed metabolic acidosis: "7.1/54/-11, sodium 119, potassium 5.3, ionized calcium 1.15".Subsequent bloodwork results: sodium 117, potassium 5.4, chloride 88, carbon dioxide 15, blood urea nitrogen (bun) 21, glucose 1195, calcium 7.3, magnesium 2.8.Due to the event, the fluid was changed to normal saline at 60ml/kg/day and sodium acetate at 20ml/kg/day to correct the electrolyte imbalance and acidosis.Bun/creatinine continued to rise over the next few days.Hypoglycemia occurred at 0424 am with interventions deployed to correct the hypoglycemia.Bloodwork was trended and glucose levels were closely monitored until returned to baseline.The vital signs were monitored closely.It was also reported that the patient experienced increase gastric residuals and intermittent emesis, wherein hyperglycemia was followed by hypoglycemia.The patient had altered electrolytes for several days despite interventions to correct imbalances.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 12621291
• MDR Text Key: 276120207
• Report Number: 2016493-2021-64631
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: (01)10885403810015
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015; 8110; 8015; 8110
• Patient Outcome(s): Required Intervention