MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LIFECARE PCA 3 V5.06; 80MEA

Catalog Number 20709

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

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

Event Date 01/01/2011

Event Type  malfunction  

Event Description

The customer contact reported the device did not alarm when a distal occlusion was present.The device was returned to the biomedical department for a report of motor slips before reaching occlusion.No tracking information was provided; therefore, specific patient information, pump reprogramming, or event details were not available.There wer no reports of any adverse patient events or delays in critical therapies while the device was in clinical use.During testing at the user facility, the device did not alarm when a distal occlusion was present.No additional information was provided.

Manufacturer Narrative

The mechanism was received.Investigation is not complete.This report represents all the information the reporter upon query by hospira personnel.

• Brand Name: LIFECARE PCA 3 V5.06
• 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: 3978692
• MDR Text Key: 4886250
• Report Number: 9615050-2014-03805
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/07/2014

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: 20709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2014
• Initial Date FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2006
• 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