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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER NEW
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HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER NEW Back to Search Results
Catalog Number 30010
Medical Device Problem Code Battery Problem (2885)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Event or Problem Description
The event occurred on an unspecified date in 2018.The event involves a customer allegation against a device that alarms n56 (replace battery).Testing confirmed that a replace battery alarm (n56) occurred during the device's self-test.The battery was charged and reset showing sufficient vdc (voltage direct current).The battery was replaced to resolve the issue.The probable cause is related to a known software issue in version 15.02.00.008.Due to the software issue, when there is a replace battery condition and the device is disconnected from ac power, the "depleted battery" alarm occurs in place of the "replace battery" alarm and causes the pump to shut down after 3 minutes.
 
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Brand Name
PLUM 360 DRIVER NEW
Common Device Name
PLUM 360 DRIVER NEW
Manufacturer (Section D)
HOSPIRA COSTA RICA LTD.
zona franca global
la aurora heredia,
CS 
MDR Report Key7777643
Report Number9615050-2018-00049
Device Sequence Number1084496
Product Code FRN
UDI-Device IdentifierM3353001004051
UDI-PublicM3353001004051
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
PMA/510(K) Number
K141789
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Biomedical Engineer
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 08/01/2018
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
Operator of Device Health Professional
Device Catalogue Number30010
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/01/2018
Initial Report FDA Received Date08/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		Z-1682-2017
Patient Sequence Number1
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