MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC. MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM; FILTER, INFUSION LINE

Catalog Number MX448FMG

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.

Event Description

It was reported that a medex¿ mangum¿ micro fluid delivery system tubing was leaking at the air filter and the bonded tip at the end of the tubing.The leak was observed in a neonatal intensive care unit and the device was in use for less than 24 hours before the leakage was discovered.The leaking system was reported to contribute to the patient not receiving the appropriate fluids.All tubing was changed to address the issue.The patient was a premature infant.The patient continued total parenteral nutrition therapy and drips and remained admitted to the neonatal intensive care unit.No permanent injury was reported.See mfr: 2183502-2016-02051, 2183502-2016-02052, 2183502-2016-02053, 2183502-2016-02055, 2183502-2016-02056, 2183502-2016-02057, 2183502-2016-02058, 2183502-2016-02059, 2183502-2016-02060, and 2183502-2016-02061.

Manufacturer Narrative

One used 74" mangum¿ micro fluid delivery system with 0.2 filter was returned for investigation.The sample was received outside of its original packaging.During functional testing, a syringe was used to infuse water into the device.During infusion, a leak was observed between the bonding of the filter and the tube.The device bonding was inspected microscopically; evidence of stress and separation of the tube was found.Investigation determined the root cause of the leak was due to mishandling of the device.(b)(4).

• Brand Name: MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS HEALTHCARE MANUFACTURING SA DE CV; carretera miguel alemán km21.7; parque industrial monterrey; apodaca nl, CP 66 603; MX CP 66603
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5970076
• MDR Text Key: 55445725
• Report Number: 2183502-2016-02054
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX448FMG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: MEDFUSION® 3500 SYRINGE PUMP