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U.S. Department of Health and Human Services

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

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UNOMEDICAL A/S MIO INFUSION SET Back to Search Results
Model Number MMT-965
Device Problem No Apparent Adverse Event (3189)
Patient Problem Death (1802)
Event Date 05/26/2016
Event Type  Death  
Manufacturer Narrative
Dated 04-nov-2016: a visual inspection and tests for flow, leak and ventilation to the pcc reservoir connector were performed on the returned used device (1 tubing). All test results were within specifications. The claimed failure cannot be confirmed. An investigation has been performed based on the customer complaint description and one returned used tubing. If new information becomes available, the complaint will be re-opened and appropriate actions will be taken.
 
Event Description
(b)(4). A diabetic patient deceased on (b)(6) 2016. Through the investigation on this incident no additional information was provided except that the patient was deceased. No copy of the death certificate or autopsy report was provided. No clinical consequences before the patient past away was reported. No lot information available. No infusion set malfunction reported. No hospital name and or hcp name reported. No information about if patient receive any medical treatment up to the time of death was reported. The coroner was supposed to contact (b)(4) (distributor) with additional information. But there was no call back from the coroner. No further information available.
 
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Brand NameMIO INFUSION SET
Type of DeviceMIO INFUSION SET
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 Key6078367
MDR Text Key59118697
Report Number3003442380-2016-00016
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051264
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/04/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-965
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2016
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 Initial

Patient Treatment Data
Date Received: 11/04/2016 Patient Sequence Number: 1
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