MAUDE Adverse Event Report: HOSPIRA HOLDINGS DE COSTA RICA LTD. PCA PLS II; 80MEA

Catalog Number 01950

Device Problems No Audible Alarm (1019); Thermal Decomposition of Device (1071); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

The customer contact reported that while operating on ac power, the device powered off by itself without sounding an audible alarm tone and electrical smell was noted from the device.The device was returned to the biomedical engineering dept.With report that the device powered off while on battery power.No tracking info was provided; therefore, specific pt info, pump programming, or event details were not available.There were no reports of any adverse pt events and no reported delays of critical therapies while the device was in clinical use.During testing at the user facility, while operating on ac power, the device powered off by itself without sounding an audible alarm tone and electrical smell was noted from the device.Though requested, no add'l info was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: PCA PLS II
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA HOLDINGS DE COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer (Section G): HOSPIRA HOLDINGS DE COSTA RICA LTD.; zona franca global; la aurora de heredia ; CS
• Manufacturer Contact: juergen schmider, m.d. ; 275 n field drive; bldg # h2-1east, dept# 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3807125
• MDR Text Key: 22138204
• Report Number: 9615050-2014-00022
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 01950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2013
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/1989
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1