MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. LS HEMA Y-TP BLD CLV; 80 FRA

Catalog Number 12434

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

The customer contact reported that one of the tubes that lead from the spike to the drip chamber was loose, subsequently a leak was noted.It was reported that during priming, prior to pt use, fluid was found around the outside of the drip chamber, the bubbles occurring at the connection when drip chamber was squeezed.It was further reported, that when the tubing set was placed back in the packaging, one of the tubes that leads from the spike to the blood filter housing assembly came apart where it entered the blood filter housing assembly.There were no reported adverse pt events and no reported delay of therapy critical for the pt.No medical interventions were required.No add'l info was provided.

Manufacturer Narrative

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

• Brand Name: LS HEMA Y-TP BLD CLV
• Type of Device: 80 FRA
• 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 ; 275 n field dr; bldg no h2-1east, dept no 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4787220
• MDR Text Key: 22252323
• Report Number: 9615050-2015-01099
• Device Sequence Number: 1
• Product Code: FRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101677
• 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: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12434
• Device Lot Number: 441365H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• 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