MAUDE Adverse Event Report: SILHOUETTE PARADIGM; COMFORT SHORT 110/13 PCC

Model Number MMT-382600

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

(b)(4).Event occurred in (b)(6).It was reported that the infusion set's tubing got disconnected while the patient was sleeping.The patient often rotates while sleeping.The site location was patient's abdomen and the pump was located on right side.Moreover, the infusion had been used for less than 24 hours.Reportedly, the infusions were stored in room temperature.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

Event Description

On 12-oct-2020: follow up information was submitted to update health effect - clinical code and result of complaint investigation of the reference samples showed that all test results were within specifications.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.It was reported that the infusion set's tubing got disconnected while the patient was sleeping.The patient often rotates while sleeping.The site location was patient's abdomen and the pump was located on right side.Moreover, the infusion had been used for less than 24 hours.Reportedly, the infusions were stored in room temperature.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: COMFORT SHORT 110/13 PCC
• MDR Report Key: 10447357
• MDR Text Key: 204167517
• Report Number: 8021545-2020-00113
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244009141
• UDI-Public: 05705244009141
• Combination Product (y/n): N
• PMA/PMN Number: K162812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2022
• Device Model Number: MMT-382600
• Device Lot Number: 5297683
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 08/17/2020
• Supplement Dates FDA Received: 10/12/2020
• Patient Sequence Number: 1