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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UNOMEDICAL A/S INFUSION SET INSET

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UNOMEDICAL A/S INFUSION SET INSET Back to Search Results
Model Number 100-182-01
Device Problem No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 10/26/2016
Event Type  Death  
Manufacturer Narrative
On 27-jan´2017: a visual inspection and tests for flow and leak were performed on the returned used device (1 set, inserted). All test results were within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and on the one returned used set. (b)(4) is actively seeking further information on this incident. (b)(4) is expected to submit an update or final report not later that 26-feb-2017. Clinical evaluation: it was reported that a patient had passed away due to inaccurate insulin delivery that was not related to site/infusion set or cartridge. More information is necessary to perform a clinical evaluation.
 
Event Description
(b)(4). This incident took place in (b)(6). Coroner reported patient passed away on (b)(6) 2016. The coroner did not provide a cause of death and it is undetermined if the pump and/or the infusion set is linked to the patients death. No further information available.
 
Manufacturer Narrative
On 03-feb-2017: this incident was reported in error. The infusion set was not related to this incident. The case is considered closed. On 27-jan-2017: a visual inspection and tests for flow and leak were performed on the returned used device (1 set, inserted). All test results were within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and on the one returned used set. Clinical evaluation: it was reported that a patient had passed away due to inaccurate insulin delivery that was not related to site/infusion set or cartridge. More information is necessary to perform a clinical evaluation.
 
Event Description
(b)(4). This incident took place in (b)(6). Coroner reported patient passed away on (b)(6) 2016. The coroner did not provide a cause of death and it is undetermined if the pump is linked to the patients death. No further information available.
 
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Brand NameINFUSION SET INSET
Type of DeviceINSET
Manufacturer (Section D)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer (Section G)
UNOMEDICAL A/S
aaholmvej 1-3
osted
lejre, 4320
DA 4320
Manufacturer Contact
aaholmvej 1-3
osted
lejre, 4320
548167000
MDR Report Key6282301
MDR Text Key65895510
Report Number3003442380-2017-00001
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number100-182-01
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/19/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/27/2017 Patient Sequence Number: 1
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