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MAUDE Adverse Event Report: HALYARD ECLIPSE HOMEPUMP
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HALYARD ECLIPSE HOMEPUMP
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Model Number
E102000
Device Problems
Crack (1135); Leak/Splash (1354)
Patient Problem
No Information (3190)
Event Date
10/12/2017
Event Type
malfunction
Event Description
Upon arrival to the infusion center, the tubing one eclipse homepump, model # e102000, lot # 0202702677, filled with daptomycin 800 mg/0.9 percent sodium chloride 100 ml was cracked and leaked.
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Brand Name
ECLIPSE HOMEPUMP
Type of Device
ECLIPSE HOMEPUMP
Manufacturer
(Section D)
HALYARD
alpharetta GA 30004
MDR Report Key
6968430
MDR Text Key
90064085
Report Number
MW5072880
Device Sequence Number
1
Product Code
MEB
Combination Product (y/n)
N
Reporter Country Code
US
Number of Events Reported
1
Summary Report (Y/N)
N
Report Source
Voluntary
Reporter Occupation
Pharmacist
Type of Report
Initial
Report Date
10/19/2017
1
Device was Involved in the Event
1
Patient was Involved in the Event
Date FDA Received
10/23/2017
Is this an Adverse Event Report?
No
Is this a Product Problem Report?
Yes
Device Operator
Health Professional
Device Model Number
E102000
Device Lot Number
0202702677
Was Device Available for Evaluation?
Yes
Is the Reporter a Health Professional?
Yes
Was Device Evaluated by Manufacturer?
No Information
Is This a Reprocessed and Reused Single-Use Device?
No
Type of Device Usage
N
Patient Sequence Number
1
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