MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LC PCA REFURB 802.11; 80MEA

Catalog Number 20709

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

Patient Problem No Patient Involvement (2645)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The customer contact report that during preventative maintenance testing at the user facility, the device did not alarm when a distal occlusion was present.There were no reports of adverse pt effects and no reported delay in critical therapies while the device was in clinical use.No medical interventions were reported.No additional info was provided.

Manufacturer Narrative

At this time the customer will not be returning the device for evaluation.The device will be repair at the user facility and returned to clinical service.If the device is received, a follow-up report will be submitted.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA REFURB 802.11
• 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, dept. no. 097u; bldg. no. h2-1 east; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4360572
• MDR Text Key: 5234466
• Report Number: 9615050-2014-06546
• 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: Other
• Type of Report: Initial
• Report Date: 12/15/2014

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2009
• 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