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

Catalog Number 20709

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The customer contact reported an error code of e630 (screw rotation error).The device was returned to the biomedical department for with an unsigned note that stated, "not working".No specific pt info, device programming, or event details were available.There were no reports of any adverse pt events or delays in critical therapies while the device was in clinical use.During testing at the user facility, the device audibly alarmed and displayed error 630 (screw rotation error).No add'l info was provided.

Manufacturer Narrative

Testing and investigation found the device alarmed for e630 (screw rotation error) malfunction alarm code.The probable cause of the malfunction alarm is due to a grease leak from the motor which caused contamination onto the optic 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 optic sensor shaft may have interfered with sensors which resulted in a 630 malfunction (screw rotation error).This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: LC PCA NEW 802.11 AB
• 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.; bldg h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4308129
• MDR Text Key: 5195748
• Report Number: 9615050-2014-06114
• 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: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2014
• 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: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2008
• 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