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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMIN, INTRAVASCULAR.
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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMIN, INTRAVASCULAR. Back to Search Results
Model Number PRI TUBING
Device Problems Disconnection (1171); Failure to Disconnect (2541)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
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 it is difficult to disconnect tubing from ultrasite valve.The nurse stated that when an ultrasite is not attached to the iv, sometimes they have difficulty disconnecting the extension set (that is added in or) from the ultrasite.No additional information was available.
 
Manufacturer Narrative
Supplemental created to update b5 and h6.
 
Event Description
It was reported that it is difficult to disconnect tubing from ultrasite valve.The nurse stated that when an ultrasite is not attached to the iv, sometimes they have difficulty disconnecting the extension set (that is added in or) from the ultrasite.There was no patient harm.No additional information was available.
 
Event Description
It was reported that it is difficult to disconnect tubing from ultrasite valve.The nurse stated that when an ultrasite is not attached to the iv, sometimes they have difficulty disconnecting the extension set (that is added in or) from the ultrasite.Follow up confirmed that there was a minor delay in treatment, however; there was no patient harm as a result of this event.No additional information has been made available to date.
 
Manufacturer Narrative
Additional information added; h.6, (device code) and d11.Correction; h.6.(patient code).The customer complaint of difficulty disconnecting tubing could not be confirmed due to the product was not returned for failure investigation.The root cause of this failure was not identified as no product was returned.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET, ADMIN, INTRAVASCULAR.
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9793017
MDR Text Key192174016
Report Number9616066-2020-00730
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/05/2020
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received04/01/2020
04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BBRAUN ULTRASITE CONNECTOR, THERAPY DATE UNKNOWN.
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