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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 Problems Insufficient Flow or Under Infusion (2182); Failure to Infuse (2340)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/17/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 250ml baxter bag lot y309807 exp dec20, 0.9% sodium chloride injection; 100ml pfizer galaxy bag lot ln118323 exp 19feb20, zosyn 4.5g (piperacillin and tazobactam injection); one alcohol cap.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
It was reported that the secondary antibiotic therapy piperacillin-tazobactam (zosyn) 4.5g/d5 100ml to be administered every 8 hours for a duration of 4 hours was hung at 0423.At 0715, the primary infusion of normal saline was found to be infusing instead of the antibiotic.Upon assessment, it was found that the secondary tubing set was unclamped and appeared to have partially infused.The infusion was stopped at 0715 and it is unknown how much of the antibiotic medication was infused.The customer further stated that there were no adverse effects caused to the adult patient from the event.
 
Manufacturer Narrative
Additional info: the suspect instrument is changed from a tubing set to a device.Please reference manufacturer report number 2016493-2019-01443 from emdr 332078.
 
Event Description
It was reported that the secondary antibiotic therapy piperacillin-tazobactam (zosyn) 4.5g/d5 100ml to be administered every 8 hours for a duration of 4 hours was hung at 0423.At 0715, the primary infusion of normal saline was found to be infusing instead of the antibiotic.Upon assessment, it was found that the secondary tubing set was unclamped and appeared to have partially infused.The infusion was stopped at 0715 and it is unknown how much of the antibiotic medication was infused.The customer further stated that there were no adverse effects caused to the adult patient from the event.
 
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Brand Name
ALARIS® PUMP MODULE ADMINISTRATION SET
Type of Device
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9089129
MDR Text Key159356222
Report Number9616066-2019-02615
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203021012
UDI-Public7613203021012
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 08/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
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
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(2 )8100, 8015, PRI TUBING, TD (B)(6) 2019
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