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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
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.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8451733
MDR Text Key139837508
Report Number9616066-2019-00748
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
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 Received03/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/26/2019 Patient Sequence Number: 1
Treatment
(3) 8100, 8015, (2) PRI TUBING, TD (B)(6) 2019
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