MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. REG NO: 9615050 LC PCA NEW 802.11 AB; 80MEA

Catalog Number 20709

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

Patient Problem No Patient Involvement (2645)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

The customer contact reported that during preventive maintenance testing at the user facility, the device did not detect an occlusion.There were no reports of any adverse patient events and no reported delays of critical therapies while the device was in clinical use.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.This report represents all the information known by the reporter upon query by hospira personnel.

Manufacturer Narrative

Initially the customer indicated that the device would be returned for investigation.Subsequently the device was not received; therefore, testing could not be performed.The device was not returned to hospira for testing and investigation; therefore, attribution of the issue to the device could not be determined.

• Brand Name: LC PCA NEW 802.11 AB
• Type of Device: 80MEA
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD. REG NO: 9615050; 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 ; 275 n field dr; bldg no h2-1 east, dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4840699
• MDR Text Key: 16635682
• Report Number: 9615050-2015-01115
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2015
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2009
• 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