MAUDE Adverse Event Report: HOSPIRA, LTD LS LF MACR EXT ST (CAS/48); 80FPA

Catalog Number 12354

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 04/06/2015

Event Type  malfunction  

Event Description

The customer contact reported particulate.The extension set was to be used to deliver an unspecified medication, at an unspecified rate.It was reported that prior to patient use, after priming, the customer contact reported that particulate was noted in the filter of the extension set.No additional information was provided.

Manufacturer Narrative

One used device was received and evaluated.Visual inspection of the device revealed a hair inside of the filter cassette.The hair is in the fluid pathway of the device.The most probable cause for this event was identified as a supplier issue.The filter is supplied by pall corporation, a supplier correction action request was sent.The investigation remains in progress.This report represents all the information known by the reporter upon query by hospira personnel.

• Brand Name: LS LF MACR EXT ST (CAS/48)
• Type of Device: 80FPA
• Manufacturer (Section D): HOSPIRA, LTD; carretera sanchez, km 18 1/2; parque industrial; haina, sancristobal ; DR
• Manufacturer (Section G): HOSPIRA, LTD; carretera sanchez, km 18 1/2; parque industrial; haina, sancristobal ; DR
• Manufacturer Contact: juergen schmider, md, vp ; 275 n. field drive; bldg. no. h2-1east, dept no. 097u; lake forest, IL 60045 ; 2242125740
• MDR Report Key: 4733349
• MDR Text Key: 5740019
• Report Number: 9613251-2015-00045
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/06/2015

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: 12354
• Device Lot Number: 472584W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2015
• Initial Date FDA Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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