MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 360 DRIVER NEW; PUMP INFUSION

Catalog Number 30010

Device Problem Low Battery (2584)

Patient Problem No Patient Involvement (2645)

Event Date 12/25/2017

Event Type  malfunction  

Event Description

The customer reported that the pump displayed low battery and replace the battery.During testing, the device alarmed for replace battery upon power up and battery icon empty during self-test.The device was powered up on ac power and the change battery soft key was pressed and the device passed all the tests on dc power.During alarm log review, multiple n56 (replace battery) alarms were found.The complaint was confirmed and the probable cause was determined to be 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.

• Brand Name: PLUM 360 DRIVER NEW
• Type of Device: PUMP INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; zona franca global,; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global,; la aurora heredia ; CS
• Manufacturer Contact: regina rose, mba, bs, mt(ascp) ; 600 n. field drive; bldg. h2-1e; lake forest, IL 60045-,USA ; 2242125740
• MDR Report Key: 7273700
• MDR Text Key: 100424424
• Report Number: 9615050-2018-00019
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2018
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-1682-2017
• Patient Sequence Number: 1