MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC., CADD SOLIS AMBULATORY INFUSION PUMP

Model Number 2100

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

Patient Problem Death (1802)

Event Date 03/09/2016

Event Type  Death  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

Patient's step-father reported that an infusion pump was being used to infuse his step-son with total parenteral nutrition (tpn).According to the reporter, the patient went to bed during an infusion, and his tpn bag was set on the floor next to his bed.It was reported that at 10:00 a.M.The next morning, the patient was found deceased.According to the reporter, a hole was found in the tpn bag, and the pump continued to run as usual without alarm.The reporter explained that an autopsy would be performed to determine cause of death.According to the reporter, the patient's pump and accessories will be kept by the patient's health care practitioner for investigation.Additional information regarding device details, accessory information, autopsy results, address info, and patient pre-conditions have been requested.No information has been provided at this time.

• Brand Name: CADD SOLIS AMBULATORY INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.,; 1265 grey fox road; st paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5548258
• MDR Text Key: 41905067
• Report Number: 2183502-2016-00722
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 2100
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death