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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). 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.
 
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Brand NameINFUSION DEVICES - UNKNOWN
Type of DeviceINFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key14404813
MDR Text Key291708171
Report Number3003442380-2022-00668
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 05/16/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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