• 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
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). On (b)(6) 2022, the patient's mother reported that in the past ((b)(6) 2020) her daughter experienced headache, vomiting, extremely nauseous and high blood glucose level due to two consecutive infusion sets that day had bent cannula and the pump did not alarm with insulin flow block so the patient was not aware right away. The site location was patient's abdomen. They were overwhelmed at the time of the event and did not report it until now. The patient was also tested for ketones at home first which were positive (above 1 mmol/l) and then consulted with the pediatrician about going into the hospital. Further, in (b)(6) 2020, the patient was admitted to the emergency room due to diabetic ketoacidosis with blood glucose level of 30 mmol/l. Moreover, the infusion set had been used for one day. While the patient was in the emergency room, she received insulin, and potassium drip as corrective treatment. After spending 12-18 hours in the emergency room, she was released in the middle of the night. 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameINFUSION DEVICES - UNKNOWN
Type of DeviceINFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14445500
MDR Text Key292498130
Report Number3003442380-2022-00669
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
Type of Report Initial
Report Date 05/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/06/2022
Was Device Evaluated by Manufacturer? No Answer Provided

-
-