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 Patient Involvement (2645)

Event Date 02/13/2015

Event Type  malfunction  

Event Description

The customer contact reported during preventive maintenance 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 add'l info was provided.

Manufacturer Narrative

Testing and investigation found the device did not alarm when a distal occlusion was present.This was due to a worn half nut.The worn threads on the half nut caused the half-nut on the lead screw to jump threads when occlusion pressure built and device failed to alarm for occlusion.The issue is caused by normal wear and tear on the half nut as it travels up and down the lead screw.As indicated, this device has been identified as part of a product recall.This report represents all the info known by 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, cri ; CS
• Manufacturer Contact: juergen schmider, md, vp, gps ; 275 n. field dr.; bldg no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4613482
• MDR Text Key: 5654258
• Report Number: 9615050-2015-00670
• 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
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 02/26/2015

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: 20709
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2015
• Initial Date FDA Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA312-07
• Patient Sequence Number: 1