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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 2477-0007
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation. Per customer, it is their policy not to provide patient demographics.
 
Event Description
It was reported that the blood tubing set was primed and no leak was observed. After loading the set into the pump, blood was seen dripping from the bottom of the pump. Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module. A tiny tear on the pump segment was noted. There was no patient harm. A photo of the product was provided by the customer. The clinician believes that the pump might have caused the tubing to tear.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION 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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9788325
MDR Text Key191285114
Report Number9616066-2020-00672
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2477-0007
Device Catalogue Number2477-0007
Device Lot Number19106339
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1768-2019

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