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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 2420-0007
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Therapeutic Response, Increased (2272)
Event Date 05/06/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 50 ml hospira bag, ndc 0409-6730-13, exp: apr 2020, magnesium sulfate injection;1000 ml baxter bag, lot y300228, exp: sept 2020, magnesium sulfate injection;100 ml baxter bag, lot 19a11g50, exp: 09/2020, 0. 9% nacl injection; curos cap;250 ml baxter bag, lot y299792, exp: sept 2020, 0. 9% nacl injection; 50 ml baxter bag, lot p387670, exp: dec 2019, kcl injection, therapy date: (b)(6) 2019. The reported issue that magnesium 4g/50ml infusion was programmed at 12. 5ml/h and within ten minutes into the infusion the patient had experienced issues that may be associated with over infusion and there being 8 ail alarms during the duration of the infusion was confirmed. Visual inspection of the set noted no damage or any anomalies. Physical inspection of the device noted fluid ingress damage to rear case with the bezel plastic and rear case plastic having signs of brittleness. Analysis of the pcu event log shows pump module s/n (b)(4) began a manually programmed infusion of the drug magnesium sulfate at 9:42am on (b)(6) 2019. The concentration was 4gram/50ml (drugid
=
275). The rate was at 12. 5ml/h and the vtbi at 50ml, both being default settings for the selected drug. Ail alarms began approximately a minute into the infusion. There were 8 ail alarm events as reported with attempts to restart the infusion, and three recorded events were the safety clamp open alarm was generated to clear the air with recorded durations at 1 second twice and 4 seconds. The pump module was turned off at 10:06am with a volume infused recorded at 2. 086ml. The cause for the ail alarms or the early termination of the infusion could not be ascertained from the log. Pressure testing resulted in no leaking. The pump module and disposable set as an infusion system infused within specification with no observed unregulated flow or having unexpected false ail alarms occurring during testing. The pump module ail assembly testing was found to be detecting the presence of air in the tubing within specification. The root cause of the customer¿s report was not determined.
 
Event Description
It was reported that a magnesium 4g/50ml infusion was programmed at 12. 5ml/hr; approximately 10 minutes into the infusion, the patient complained of chest tightness, redness and flushing. The pump was paused. The customer did not allege that an over infusion occurred. They also stated that there were 8 air in line alarms during the duration of the infusion. There was no lasting harm. Although requested, no further information was received.
 
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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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8848273
MDR Text Key152919614
Report Number9616066-2019-02108
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 health professional,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Is the Reporter a Health Professional?
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: 07/31/2019 Patient Sequence Number: 1
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