MAUDE Adverse Event Report: CADD-SOLIS AMBULATORY INFUSION PUMP LOCKBOX; PUMP, INFUSION

Catalog Number	21-2188-25
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was in use with patient for infusion of narcotic.Reporter stated the patient was able to break into the lockbox without key by manipulating the casing and the pins holding the door closed.No adverse effects to patient reported.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP LOCKBOX
• Common Device Name: PUMP, INFUSION
• MDR Report Key: 8006274
• Report Number: 3012307300-2018-04399
• Device Sequence Number: 13750511
• Product Code: FRN
• UDI-Device Identifier: 10610586035029
• UDI-Public: 10610586035029
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K080743
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2018

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
• Operator of Device: No Information
• Device Catalogue Number: 21-2188-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1