MAUDE Adverse Event Report: ADVANCED INFUSION, INC. ALPHA; PUMP, INFUSION, ELASTOMERIC

Model Number 450

Device Problems Crack (1135); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2014

Event Type  No Answer Provided  

Event Description

While scrub tech was filling pump prior to starting procedure, it cracked making a loud "gunshot sounding" noise.No fluid leaked out.The patient was not near the device.

• Brand Name: ALPHA
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): ADVANCED INFUSION, INC.; 466 west arrow hwy., unit h; san dimas CA 91773
• MDR Report Key: 4275264
• MDR Text Key: 21085624
• Report Number: 4275264
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/18/2014

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?: *
• Device Operator: Other
• Device Model Number: 450
• Device Catalogue Number: A450
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2014
• Patient Sequence Number: 1