MAUDE Adverse Event Report: AMBIT AMBIT PCA AMBULATORY PUMP; PUMP, INFUSION, PCA

Model Number EXTERNAL PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Event Description

A patient death was reported for a patient undergoing a morphine trial with an ambit pump.The date of death was not provided.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMBIT PCA AMBULATORY PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): AMBIT
• MDR Report Key: 17524138
• MDR Text Key: 321040647
• Report Number: MW5131085
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: EXTERNAL PUMP
• Patient Sequence Number: 1