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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORP ALARIS PUMP MODULE ADMINISTRATION SET; INFUSION SET
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CAREFUSION CORP ALARIS PUMP MODULE ADMINISTRATION SET; INFUSION SET Back to Search Results
Model Number 2426-0500
Device Problems Break (1069); Contamination (1120); Chemical Spillage (2894)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2014
Event Type  malfunction  
Event Description
Customer reported a tear in the primary tubing at the connection between the upper fitment and the silicone segment while infusing chemotherapy.The chemotherapy leaked onto the infusion pump.Two bags were attached to the primary tubing: cytarabine 6000mg and normal saline flush.There was no patient harm and medical intervention was not required.No further patient/event information was provided.(b)(4).
 
Manufacturer Narrative
(b)(4).The affected product has been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation is completed.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
INFUSION SET
Manufacturer (Section D)
CAREFUSION CORP
san diego CA
Manufacturer Contact
barbara ferris
10020 pacific mesa blvd
san diego, CA 92121
8586171163
MDR Report Key3964162
MDR Text Key4607033
Report Number9616066-2014-00478
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 Other,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/19/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/01/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Treatment
SECONDARY SET, MODEL 10013364T, LOT UNK; ALARIS PUMP MODULE (B)(4); ALARIS PCU SN (B)(4); ALARIS PUMP MODULE (B)(4)
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