MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Foreign: (b)(6).On (b)(6) 2022, the patient's mother reported that her daughter had vomiting and experienced high blood glucose level of 589 mg/dl, and it started increasing but she tried to deliver a bolus, but it was not working.Therefore, she decided to remove the infusion set and noticed that the cannula was completely bent, and the blood glucose level was so high, so she decided to take her to the emergency room on (b)(6) 2022.The infusion set was also changed the same day ((b)(6) 2022).Reportedly, her ketone level was 7.35 mmol/l, and she was administered insulin drip intravenously.Moreover, she stated that she was disconnected from pump, when she went back home but when it was reconnected, the same thing happened, and blood glucose levels started to increase.So, she took infusion set out and found that the cannula was bent but the pump did not alarm of her that infusion was blocked.She was released after fourteen days.Currently, (at the time of the call) her blood glucose level was 385 mg/dl.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.

• Brand Name: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14404813
• MDR Text Key: 291708171
• Report Number: 3003442380-2022-00668
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/08/2022
• Patient Sequence Number: 1