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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 on (b)(6) 2023, the patient faced a bent cannula which led to high blood glucose level.Therefore, they tried to treat it with bolus via pump, but on the same day (b)(6) 2023, the patient went to the emergency room and was subsequently hospitalized due to high blood glucose level.The patient's highest blood glucose level was above 22.2 mmol/l and had high ketone level which the healthcare professional assessed as dangerous/life threatening.Moreover, the infusion set had been used under 24 hours.Further, the patient was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified (drug name unknown) medication as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.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 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 Key18441805
MDR Text Key331865043
Report Number3003442380-2024-00106
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 01/04/2024
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? No
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 12/26/2023
Initial Date FDA Received01/04/2024
Patient Sequence Number1
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