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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 Problem Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/13/2019
Event Type  malfunction  
Manufacturer Narrative
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 during an infusion of alteplase at an unspecified rate, the night shift rn stated the iv tubing set "exploded" and was replaced with new tubing, however; the device continued to alarm for occlusion.The rn flushed the picc line by disconnecting tubing and received a positive blood return.After twenty minutes later; the device alarmed again for occlusion alarms; after flushing , the device alarmed again, the user opened the door to the device and observed a bulge in the silicone segment.The rn then changed out the devices to a new pump and new iv tubing, and the device infused without difficulty.There was no patient impact.
 
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
It was reported that during an infusion of alteplase at an unspecified rate, the night shift rn stated the iv tubing set "exploded" and was replaced with new tubing, however; the device continued to alarm for occlusion.The rn flushed the picc line by disconnecting tubing and received a positive blood return.After twenty minutes later; the device alarmed again for occlusion alarms; after flushing , the device alarmed again, the user opened the door to the device and observed a bulge in the silicone segment.The rn then changed out the devices to a new pump and new iv tubing, and the device infused without difficulty.There was no patient impact.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9298066
MDR Text Key195089367
Report Number9616066-2019-03169
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number2420-0007
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(2)8100,8015, THERAPY DATE 10/13/2019
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