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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUICK-SET® PARADIGM® QUICK-SET 80/9 PCC
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QUICK-SET® PARADIGM® QUICK-SET 80/9 PCC Back to Search Results
Lot Number 5143608
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  malfunction  
Event Description
Unomedical reference number (b)(4). Event occurred in the united states. The patient reported, she had faced tubing detachment issue three times. The infusion sets detached for the first time while she was at work, second time while she was sleeping and the third-time next day around lunch. The location of the detachment was at quick release. The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity. There was no stress or pull on the tubing. The pump was dropped once, when she woke and got up, it fell as she did not realize that the pump had detached. The patient when to the emergency room due to diabetic ketoacidosis and threw the set at hospital. Reportedly, she stayed at hospital for one and half day. No further information available.
 
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Brand NameQUICK-SET® PARADIGM®
Type of DeviceQUICK-SET 80/9 PCC
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
MDR Report Key8202007
MDR Text Key131586755
Report Number3003442380-2018-00135
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2019
Device Lot Number5143608
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/28/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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