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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD INC. MEDEX¿ MANGUM¿ MICRO FLUID DELIVERY SYSTEM; FILTER, INFUSION LINE Back to Search Results
Catalog Number MX448FMG
Device Problem Leak/Splash (1354)
Patient Problem Low Blood Pressure/ Hypotension (1914)
Event Date 08/23/2016
Event Type  malfunction  
Manufacturer Narrative
Pt age: approx (b)(6) days old.Pt weight: approx.(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 tubing was used with a vasopressor and the infant was noted to have decreasing blood pressure.The investigation by the customer revealed that the line that contained the vasopressor was leaking.All tubing was changed to address the issue.The leaking system was reported to contribute to the patient not receiving the appropriate fluids.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: 2183502-2016-02052, 2183502-2016-02053, 2183502-2016-02054, 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 infusion, a leak was observed at the stopcock site.The bond was inspected microscopically, and a lack of solvent was identified.Investigation determined that the root cause of the leakage was related to a lack of solvent during the bonding process.(b)(4).
 
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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 Key5970071
MDR Text Key55443031
Report Number2183502-2016-02051
Device Sequence Number1
Product Code FPB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K860803
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMX448FMG
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/11/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/25/2016
Initial Date FDA Received09/22/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/02/2016
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 Number1
Treatment
MEDFUSION 3500 SYRINGE PUMP
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