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

Model Number 8100

Device Problems Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problem Burning Sensation (2146)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 1000 ml baxter, lot # y282897, exp: 03/2020, 10% dextrose injection; 1000 ml, lot # y308833, exp: 12/2020, 0.45% sodium chloride injection; 100 ml, lot # p390922, exp: 09/2020, 0.9% sodium chloride injection; y-site, tri-fuse, peripheral iv.The customer¿s report of an over-infusion of potassium phosphate was not confirmed.Physical inspection of the device noted no issues or damage.Review of the pcu event logs confirmed that on the date / time of the reported event a potassium phosphate infusion was programmed as a primary infusion.The infusion was started at a rate of 16.6698 ml / hr and infused for approximately 9 minutes before being powered off.Timed rate accuracy testing was performed.The system was found to be in specification with no issues observed.During testing there were no periods of unregulated flow observed.Although the silicone segment was found to be marginally out of specifications, it is not believed that this contributed to the customers reported event.The starting / ending volume of the fluid container cannot be determined through device logs.Internal and external inspection was performed and no issues were found that would have contributed to the customers reported free flow event.The root cause of the customer complaint of an over-infusion of potassium phosphate was not identified.

Event Description

It was reported that in the pediatric icu at 1509, the nurse programmed a pump module for a primary infusion of normal saline 100 ml with potassium phosphate 15 mmol to infuse at a rate of 16.7 ml/hr over six hours via a y-connector below the pump.Another primary infusion of 1/2 normal saline with potassium chloride 20 meq and potassium phosphate 20 meq was infusing at 35 ml/hr, and was attached to a tri-fuse attached to a peripheral iv.At 1516, the patient reported burning in her arm and the nurse noticed that the entire bag of normal saline 100 ml with potassium phosphate 15 mmol had infused within seven minutes.The nurse stopped the pump module and reported the problem.Labs were obtained and showed that the potassium level remained low and the patient required additional potassium phosphate.The patient's ekg was normal.In addition, there were two other infusions at the time of the event; insulin 100 units/100 ml (1:1) infusing at 2.4 ml/hr which was ordered at 0.05 u/kg/hr and dextrose 10% water with potassium chloride 20 meq, potassium phosphate 20 meq, and sodium chloride 77 meq infusing at 105 ml/hr.There was a standing order for glucose checks every hour and (epoc) bedside lab testing every four hours.The patient's glucose check continued every hour, but the bedside lab testing was increased to every hour x3, then every two hours x12 and then went back to protocol; every four hours.The patient's potassium levels were 2.5 to 3.0 meq/l and phosphate level was 3.6 mg/dl.The customer states there was no harm to the patient.

Event Description

It was reported that in the pediatric icu at 1509, the nurse programmed a pump module for a primary infusion of normal saline 100ml with potassium phosphate 15mmol to infuse at a rate of 16.7 ml/hr over six hours via a y-connector below the pump.Another primary infusion of 1/2 normal saline with potassium chloride 20meq and potassium phosphate 20meq was infusing at 35ml/hr, and was attached to a tri-fuse attached to a peripheral iv.At 1516, the patient reported burning in her arm and the nurse noticed that the entire bag of normal saline 100ml with potassium phosphate 15mmol had infused within seven minutes.The nurse stopped the pump module and reported the problem.Labs were obtained and showed that the potassium level remained low and the patient required additional potassium phosphate.The patient's ekg was normal.In addition, there were two other infusions at the time of the event; insulin 100units/100ml (1:1) infusing at 2.4ml/hr which was ordered at 0.05u/kg/hr and dextrose 10% water with potassium chloride 20meq, potassium phosphate 20meq, and sodium chloride 77meq infusing at 105ml/hr.There was a standing order for glucose checks every hour and (epoc) bedside lab testing every four hours.The patient's glucose check continued every hour, but the bedside lab testing was increased to every hour x3, then every two hours x12 and then went back to protocol; every four hours.The patient's potassium levels were 2.5 to 3.0 meq/l and phosphate level was 3.6mg/dl.The customer states there was no harm to the patient.

Manufacturer Narrative

The customer complaint of an over-infusion of potassium phosphate was not confirmed or replicated during the investigation.Review of the pcu event logs confirmed that on the date/time of the reported event a potassium phosphate infusion was programmed as a primary infusion.The infusion was started at a rate of 16.6698ml/hr and infused for approximately 9 minutes before being powered off.Timed rate accuracy testing was performed with the device operating at the customers observed rate for one hour.The system was found to be in specification with no issues observed.During testing there were no periods of unregulated flow observed.Although the silicone segment was found to be marginally out of specifications, it is not believed that this contributed to the customers reported event.The starting/ending volume of the fluid container cannot be determined through device logs.Internal and external inspection was performed and no issues were found that would have contributed to the customers reported free flow event.The system was being used for treatment.The mechanism assembly was disassembled during the investigation and will be replaced by service.Mechanism assemblies cannot be reassembled since manufacturing performs several tests not available to cad, service depot or the customer.Manufacturing tests involve an occluder spring test, an x-ray spring inspection and installation of new one-time use torque screws with applied tamper seal material.A review of the device history record in sap for sn (b)(4) was performed from the date of the manufacture to date of the release of product, which confirmed that this device was not involved in a production failure, and product was returned for servicing which correlates to the customer reported issue.A review of the complaint history record in the trackwise was performed for the sn (b)(4) which confirmed no similar complaints with the same or related failure mode.

• Brand Name: ALARIS PUMP MODULE
• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8928699
• MDR Text Key: 160218559
• Report Number: 2016493-2019-01025
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403810015
• UDI-Public: 10885403810015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K950419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2017
• 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: (3)8100,8015,(3)2426-0007,PRI TUBING, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female
• Patient Weight: 53 KG