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

Catalog Number 21-2112-0300-50

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

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765)

Event Date 07/28/2016

Event Type  Injury  

Manufacturer Narrative

Age: 20-44 years.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.Customer reported they quarantined the device and are downloading the data from the pump to determine if there was a connection between pump and event.

Event Description

It was reported that a cadd - solis ambulatory infusion pump was in use for infusion of patient controlled epidural analgesia when the patient experienced respiratory and cardiac arrest in a hospital.The patient required advanced life support, was admitted to the intensive care unit for one day, and spent four additional days on the inpatient unit.The patient was subsequently discharged from the hospital.No permanent injury was reported.

• Brand Name: CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: lisa perz ; 1265 grey fox rd.; st. paul, MN 51122 ; 7633833074
• MDR Report Key: 5937190
• MDR Text Key: 54225410
• Report Number: 2183502-2016-01941
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-2112-0300-50
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/12/2016
• Initial Date FDA Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention