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

Catalog Number 01950

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/24/2015

Event Type  malfunction  

Event Description

The customer contact reported during testing at the user facility, the device did not pass the occlusion test.No information was provided; therefore, specific patient information, device programming, or event details were not available.There were no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

At this time the customer will not be returning the device for evaluation.If the device is received, a follow-up report will be submitted.Although the device was not returned for testing and investigation, as indicated, the device has been identified as part of a product recall.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: PCA PLS II
• Type of Device: 80MEA
• 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 ; 275 n. field drive; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4742016
• MDR Text Key: 5822399
• Report Number: 9615050-2015-01036
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/16/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 04/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/1990
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA301-03
• Patient Sequence Number: 1