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

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Patient Involvement (2645)

Event Date 07/21/2014

Event Type  malfunction  

Event Description

The device was returned to the service center with a report of an e60 alarm and will not power on.These are not reportable malfunctions.However, during verification testing at the service center, the device alarmed with an e630 (screw rotation error) error code.

Manufacturer Narrative

Testing and investigation found the device alarmed with an e630 (screw rotation error) error code.The probable cause for the 630 malfunction was due to grease that leaked onto the opto sensor.A slotted optical interrupter sensor onto the opto sensor.A slotted optical interrupter sensor monitors a mechanical flag coupled to the rotation of the lead screw with a flat extension.Each revolution opens and closes the slotted optical path.The connections to the sensor are combined with the motor.The grease that leaked onto the opto sensor shaft may have interfered with sensors which resulted in a 630 malfunction (screw rotation error).This report represents all the information 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 de heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider, md ; 275 n. field drive; bldg. no h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4190185
• MDR Text Key: 17695337
• Report Number: 9615050-2014-05302
• 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
• Type of Report: Initial
• Report Date: 08/14/2014

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?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/03/2014
• Initial Date FDA Received: 09/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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