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U.S. Department of Health and Human Services

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

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CAREFUSION ALARIS PUMP MODULE SET SET,ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 10010454
Device Problems Partial Blockage (1065); Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: fresenius kabi freeflex, ecoflac plus 500ml,iv bag/bottle, iv flush syringe unknown manufacturer (b)(4). Requested patient demographics however customer declined to answer. Although requested, product has not been received. A follow up report will be submitted with failure investigation results should the product be received for evaluation.
 
Event Description
It was reported that the rn initiated the clinical trial compound c1d1 infusion of 9-ing-41(103 mg/ 520 ml/0. 2mg/ml/0. 1-1mg/ml) routinely administered over 1hr using a 0. 2 filter set. Approximately 30 mins. Into the infusion, the device alarmed for occlusion alarms, patient received 310ml of the total 520ml infusion. The rn flushed the line which was patent and received good blood return. The device was then restarted however the device continued with occlusion alarms. The filter tubing was disconnected after multiple techniques were attempted to fix the occlusion, including changing pump channel, adding 120cc air into collapsed bag and adjusting the connections. The bag and tubing were taken back to pharmacy and tubing was disconnected, wasting approximately 26ml of solution which was destroyed. A new 0. 2 micron filter tubing was attached and primed with the trial compound solution. After restarting the infusion, approximately 154ml infused, the device alarmed for occlusion alarms, the infusion was stopped and the remaining unspecified volume was discarded. The event occurred in the oncology clinic. It was later reported that the customer switched to a 1. 2 micron in-line filter for the clinical trial without any issues due to a larger filter. There was no report of patient harm.
 
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Brand NameALARIS PUMP MODULE 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 Key8459773
MDR Text Key140327730
Report Number9616066-2019-00868
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
Type of Report Initial
Report Date 02/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10010454
Device Catalogue Number10010454
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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