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

Model Number 2426-0500

Device Problems Stretched (1601); Material Deformation (2976)

Patient Problems Death (1802); Loss Of Pulse (2562)

Event Date 02/28/2019

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: central line, 500ml baxter bag ndc (b)(4); td (b)(6) 2019.The customer¿s report of a silicone bulge in the pump segment was confirmed.Visual inspection of the set observed that the silicone segment tubing had a bulge near the upper portion of the upper fitment.Functional testing was unable to replicate the ballooning.Additional testing of the set was conducted.An iv push was performed first by occluding the tubing above the injection port, and then again without occluding the tubing.The iv push performed without occluding the tubing above the injection port identified a balloon when the device door was opened.The root cause of the balloon in the silicone segment was due to an iv push medication or flush executed below the pump without first clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to balloon.

Event Description

The customer reported that an icu patient had 20% dextrose solution (500ml) infusing which was programmed at 50 ml/hr as a continuous primary infusion.There were other infusions running at this time (epinephrine, levophed, neosynephrine, vasopressin, sodium bicarbonate) via right internal jugular central line.At 0845, the patient was found to have pulseless electrical activity, a code blue was called.The patient's blood sugar was checked at 0835 (117 mg/dl) and at 0856 (225 mg/dl).The code blue lasted until 0928 when the patient was pronounced dead.The rn assessed the pumps and infusion sets after the event, a bulge was found in the pumping segment of the d20 infusion set.It was reported that there were no boluses or flushes given at that time, nor was the line clamped or pinched.The customer stated there were no clinical effect on the patient from the bulge.

Event Description

The customer reported that an icu patient had 20% dextrose solution (500ml) infusing which was programmed at 50 ml/hr as a continuous primary infusion.There were other infusions running at this time (epinephrine, levophed, neosynephrine, vasopressin, sodium bicarbonate) via right internal jugular central line.At 0845, the patient was found to have pulseless electrical activity, a code blue was called.The patient's blood sugar was checked at 0835 (117 mg/dl) and at 0856 (225 mg/dl).The code blue lasted until 0928 when the patient was pronounced dead.The rn assessed the pumps and infusion sets after the event, a bulge was found in the pumping segment of the d20 infusion set.It was reported that there were no boluses or flushes given at that time, nor was the line clamped or pinched.The customer stated there was no clinical effect on the patient from the bulge.

Manufacturer Narrative

Additional information added to heath professional.The customer¿s report of a silicone in the pump segment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.During visual inspection of the set it, was noted that the silicone segment tubing had a ballooned bulge near the upper portion of the upper fitment.No other anomalies were observed with the returned set.Functional testing was performed by filling a lab iv bag with blue-dyed water and attaching the set and lab extension set allowing fluid to flow through the set via gravity.The set flowed freely and ran with no issues observed.The set was re-primed with water and the observed bulge segment deflated due to the relief in pressure.The set was loaded into a pump moduleand a primary infusion was programmed at a rate of 50ml/h and vtbi 125ml for 1 hour as reported by the customer.No occlusion alarms or any other issues were noted by each device.No bulge/balloon was observed in the silicone segment when the device door was opened after infusion was completed.The root cause was not identified.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8451733
• MDR Text Key: 139837508
• Report Number: 9616066-2019-00748
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (3) 8100, 8015, (2) PRI TUBING, TD (B)(6) 2019; (3) 8100, 8015, (2) PRI TUBING, TD (B)(6) 2019
• Patient Outcome(s): Death
• Patient Age: 59 YR
• Patient Weight: 86