MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD LC PCA HOSPIRA MEDNE; 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 that during testing at the user facility, the device did not alarm when a distal occlusion was present.The device was returned to the biomedical department for an unspecified reason.No tracking information was provided; therefore, specific pt information, device programming, or event details were not available.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.Though requested, no additional information was provided no additional information was provided.

Manufacturer Narrative

The device was not isolated or identified by serial number; therefore, it will not be returned for investigation.The device was not returned to hospira for testing and investigation; therefore, attribution of the issue to the device could not be determined.This report is being made as part of a retrospective review.No further testing or investigation will be performed.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA HOSPIRA MEDNE
• 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 vice pres ; 275 n field drive; bldg no h2-1east dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3806738
• MDR Text Key: 22137695
• Report Number: 9615050-2014-00472
• 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: 10/19/2011

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: 10/19/2011
• Initial Date FDA Received: 01/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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