MAUDE Adverse Event Report: UNOMEDICAL A/S SILHOUETTE PARADIGM INFUSION SET; COMFORT

Model Number MMT-378

Device Problem Bent (1059)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Diabetic Ketoacidosis (2364); Coma (2417)

Event Date 12/19/2014

Event Type  Death  

Manufacturer Narrative

May 25, 2016: the reference samples were visually inspected and tested for flow, leak and ventilation to the pcap connector.All test results were within specifications.Batch record 5060841 was verified and found within specification.Based on the investigation and test results the claimed failure can not be confirmed.If new information becomes available the complaint will be re-opened and appropriate actions will be taken.Clinical evaluation: the spouse of patient informed pump distributor that patient had died two years ago from cardiopulmonary arrest, cardiac arrest, multiple embolic cvas due to diabetic ketoacidosis.It is reported that the patient's insurance switched patient from steel needle to a soft cannula infusion set.No information regarding the retraining of the patient due to new infusion set has been documented.The spouse reported that the patient experienced bent cannula.The spouse stated taking patient to the local hospital and they wanted to run a bunch of tests on patient and then they didn't have the right equipment, were falling all over each other, the situation was handled poorly and they couldn't admit the patient because patient was too sick for that hospital.Spouse informed the hospital tried to get an air flight out but the snow was coming and patient couldn't get a flight out to the next hospital.By the time patient got to the other hospital patients blood glucose level was still in the 1400s.Patient was in a coma for 10 days before spouse do stop life sustaining treatment (ventilator).Patient lived 45 minutes and then passed away.Based on available information the chain of events is not clear and no information regarding treatment at the first hospital is available.Due to the reported blood glucose level at 1400 mg/dl when admitted to hospital 2 it seems unlikely that hospital 1 treated the diabetic ketoacidosis as per consensus guidelines.

Event Description

(b)(4).The husband reported death of his diabetic wife on pump therapy at hospital on (b)(6) 2014.It is reported that the patient's insurance switched patient from steel needle to a soft cannula infusion set.No information regarding the retraining of the patient due to new infusion set has been documented.The spouse reported that the patient experienced bent cannula.On (b)(6) 2014 the spouse stated taking patient to the local hospital and they wanted to run a bunch of tests on patient and then they didn't have the right equipment, were falling all over each other, the situation was handled poorly and they couldn't admit the patient because patient was too sick for that hospital.Spouse informed the hospital tried to get an air flight out but the snow was coming and patient couldn't get a flight out to the next hospital.By the time patient got to the other hospital patients blood glucose level was still in the 1400s.Patient was in a coma for 10 days before spouse stops life sustaining treatment (ventilator).Patient lived for a further 45 minutes and then passed away on (b)(6) 2014.Official cause of death reported: cardiopulmonary arrest, cardiac arrest, multiple embolic cvas due to diabetic ketoacidosis.No further information available.

• Brand Name: SILHOUETTE PARADIGM INFUSION SET
• Type of Device: COMFORT
• 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: 5681115
• MDR Text Key: 45955695
• Report Number: 8021545-2016-00002
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002138
• 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: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2019
• Device Model Number: MMT-378
• Device Lot Number: 5060841
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/23/2016
• Initial Date FDA Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2014
• 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; Hospitalization