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

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.

• Brand Name: MIO INFUSION SET
• Type of Device: MIO 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 Key: 6078367
• MDR Text Key: 59118697
• Report Number: 3003442380-2016-00016
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051264
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death