Device Problem
Moisture Damage (1405)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The pump has not been returned to animas for evaluation.If the device is returned, an evaluation shall be completed and a supplemental report will be filed.No conclusions can be made at this time.This report is made under the requirements of the medical device reporting regulations and does not constitute an admission on the part of animas of any deficiency in the performance of the device.
|
|
Event Description
|
On (b)(6) 2016, the reporter contacted animas alleging a casing/condition (moisture ingress) issue.It was reported that there was moisture ingress in the battery compartment.There is no indication that the product issue caused or contributed to an adverse event.This complaint is being reported because the alleged malfunction has the ability to result in a delay in treatment or long term cessation in delivery if the damage impacts the power circuit or cartridge compartment.
|
|
Manufacturer Narrative
|
Follow-up # 1 date of submission 12/14/2016 device evaluation: the device has been returned and evaluated by product analysis on 11/22/2016 with the following findings: during visual inspection of the pump, it was observed that the battery compartment was cracked and there was evidence of moisture corrosion in the compartment and the motor flex connector.A leak test was performed and failed due to the battery compartment leak.The battery cap and cartridge cap were not returned with the pump and test caps were used to complete the investigation.Animas has conducted a review of the device history record for this pump and confirmed that it was operating within required specifications at the time of release.
|
|
Search Alerts/Recalls
|