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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN
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INFUSION DEVICES - UNKNOWN Back to Search Results
Lot Number UNKNOWN
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that the patient faced a bent cannula due to which the patient experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump and multiple daily injection, but on (b)(6) 2023, the patient was first went to the emergency room and was subsequently hospitalized due to high blood glucose level.The patient's highest blood glucose level was 48.0 mmol/l and had moderate ketone level which was not assessed as dangerous/life threatening by the healthcare professional.Moreover, the infusion had been used for two days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.Moreover, this similar issue occurred with five similar types of infusion sets three or more hours after insertion and the site location was patient's abdomen.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.
 
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Brand Name
INFUSION DEVICES - UNKNOWN
Type of Device
INFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key18482242
MDR Text Key332491778
Report Number3003442380-2024-00115
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Date Manufacturer Received01/05/2024
Patient Sequence Number1
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