MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PCA PLS II; 80MEA

Catalog Number 01950

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

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The customer contact reported that 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 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.

• Brand Name: PCA PLS II
• 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 gps ; 275 n. field dr.; during preventive maintenance testing at the user facility,; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 3901951
• MDR Text Key: 4650792
• Report Number: 9615050-2014-01373
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K912928
• 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: 01/22/2014

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: 01950
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/1993
• 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