MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLM SOL 2INTG CLAVE; 80

Catalog Number 11948

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2015

Event Type  malfunction  

Event Description

The customer contact reported particulate.It was reported that during priming, prior to pt use, a floating material, shaped like a black dot, was noted in the soluset of the tubing set.There were no reported adverse pt effects and no reported delay of therapy critical to this pt.No medical interventions were required.No additional info was provided.

Manufacturer Narrative

The device was received.Investigation is not complete.This report represents all the info known by the reporter upon query by hospira personnel.

• Brand Name: PLM SOL 2INTG CLAVE
• Type of Device: 80
• 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. no. h2-1e, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4762912
• MDR Text Key: 5783246
• Report Number: 9615050-2015-01086
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K982159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11948
• Device Lot Number: 3707055H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1