MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD LIFECARE PCA 3 V4.1; 80MEA

Catalog Number 12384

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

Patient Problem No Patient Involvement (2645)

Event Date 03/13/2014

Event Type  malfunction  

Event Description

The customer contact reported that during testing at the user facility, the device did not alarm when a distal occlusion was present.There were no reports of any adverse pt events and no reported delays of critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

Testing and investigation found the device did not alarm when a distal occlusion was present.This was due to worn threads on the half nut.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: LIFECARE PCA 3 V4.1
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD; zona frana global; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md, vice pres ; 275 n field drive; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4076888
• MDR Text Key: 4858299
• Report Number: 9615050-2014-03895
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043256
• 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: 05/13/2014

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: 12384
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2014
• Initial Date FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2004
• 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