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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number 2420-0007
Device Problems False Alarm (1013); Infusion or Flow Problem (2964)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 05/18/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products-contracting and sourcing admin. The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed. Patient age and dob requested but not provided, however the customer stated that the patient was an adult patient.
 
Event Description
It was reported that the infusion nitroglycerin 50mg/5% dextrose 250ml glass bottle tubing set was placed into the primary pump module while being piggybacked into a running primary infusion of 0. 9% nacl infusing at a rate of 100ml/hour. The nitroglycerin glass bottle was spiked, the tubing set vented and primed without difficulty. The nitroglycerin infusion was initiated at a rate of 10mcg/minute which is the facilities standard starting rate on an adult patient. Immediately after the infusion was initiated the device alarmed "occluded patient side" while the primary infusion tubing set displayed no occlusions. The secondary tubing set clamps were checked and found to be open. This was confirmed by a second rn. Suspecting that the tubing set was faulty, the rn disconnected the secondary tubing set from the primary tubing set and held it over a waste basket and restarted the pump module. The device continued to alarm "occluded patient side"' despite the secondary tubing set being disconnected. The secondary tubing set was removed from the pump module with the safety clamp opened and it was found that the nitroglycerin proceeded to flow freely. This was repeated with two other tubing sets, testing each set in two different pump channels only to have the devices to continue to alarm "occluded patient side. " the nacl was infusing via channel a and the nitroglycerin was tried on channels b and c. No extension tubing sets were used. The patient remained slightly hypertensive immediately post-operatively. Although there was no direct harm immediately noticed, an order was eventually obtained for the initiation of a nicardipine infusion.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
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 Key8707485
MDR Text Key148290801
Report Number9616066-2019-01668
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/10/2021
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number18033007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2018
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: 06/18/2019 Patient Sequence Number: 1
Treatment
(3)8100,8015, THERAPY DATE: (B)(6) 2019
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