MAUDE Adverse Event Report: HOSPIRA, LTD LS LF REG EXT SET NON-DEHP; 80FPK

Catalog Number 20667

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2014

Event Type  malfunction  

Event Description

General report rec'd of an unspecified number of undocumented incidents of separations.On unspecified dates, the tubing sets were being used to deliver unspecified concentrations of vancomycin via gravity.After unspecified lengths of times after the deliveries were started, the tubing separated from the outlet port on the dial-a-flow of the tubing sets and unspecified volumes of solution leaked.The tubing sets were replaced and the therapies were resumed.There were no reports of adverse pt effects and no reported delay in therapies critical to these pts.No medical interventions were required.Though requested, no add'l info was provided.

Manufacturer Narrative

One sealed device was rec'd and evaluated.The device passed testing.No tubing separations were noted.Although the device passed testing, during the investigation, a probable cause for the customer reported separation was identified.The probable cause of the separation could have been due to insufficient solvent application during mfg.This report represents all the info known by the rptr upon query by hospira personnel.

• Brand Name: LS LF REG EXT SET NON-DEHP
• Type of Device: 80FPK
• 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: 3821124
• MDR Text Key: 4447991
• Report Number: 9613251-2014-00082
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063239
• 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: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 20667
• Device Lot Number: 340324W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/02/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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