Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INFUSION DEVICES - UNKNOWN Back to Search Results
Lot Number UNKNOWN
Device Problem Infusion or Flow Problem (2964)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient's mother reported that her 18-years-old female child patient's insulin therapy was suspended without her awareness.In the morning, she noticed an occlusion alarm and all deliveries were suspended which led to her high blood glucose level.Therefore, they tried to treat it by changing the infusion set, but was unsuccessful, on (b)(6) 2024, the patient first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Further, the patient was transferred to the intensive care unit.She had high ketone level which healthcare professional assessed as dangerous or life-threatening.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) 2024, the patient was released from the hospital with no permanent damage.No further information was available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INFUSION DEVICES - UNKNOWN
Type of Device
INFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key18786796
MDR Text Key336285171
Report Number3003442380-2024-00164
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 02/27/2024
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 02/21/2024
Initial Date FDA Received02/27/2024
Patient Sequence Number1
-
-