MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLUM 2 FLTR PP SITE PE ORANGE 104IN NDHP

Catalog Number 14256

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  malfunction  

Event Description

The customer contact reported particulate.The tubing set was being used to delivery an unspecified concentration of taxotere, at an unspecified rate, via a plum pump.After 140 ml had been delivered, it was reported that the pump alarmed for occlusion.At this time, ti was reported that the staff noted particulate in the filter, near the y-site of the tubing set.The particulate was described as floating white particles which appeared to be part of the filter.The customer contact reported that prior to use, no particulate was noted in the solution container or in the tubing set.The customer contact reported a delay of therapy of approximately 15 minutes to remake the medication; however, there were no reported adverse patient effects.No medical interventions were reported.No additional information was provided.

Manufacturer Narrative

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

• Brand Name: PLUM 2 FLTR PP SITE PE ORANGE 104IN NDHP
• 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. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4297458
• MDR Text Key: 5053844
• Report Number: 9615050-2014-06249
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14256
• Device Lot Number: 440705H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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
• Treatment: TAXOTERE: (B)(4)