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

Catalog Number 01950

Device Problems Occlusion Within Device (1423); Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

The customer contact reported that during preventive maintenance testing at use facility, the device did not pass the occlusion test.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.No additional info was provided.

Manufacturer Narrative

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

• Brand Name: PCA PLS II
• Type of Device: 80 MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md vp gps ; 275 n field drive, bldg no h2-1east, dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4239257
• MDR Text Key: 4988110
• Report Number: 9615050-2014-05861
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/14/2014

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
• Device Operator: Health Professional
• Device Catalogue Number: 01950
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/1992
• 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