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

Model Number 2100

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/13/2015

Event Type  Death  

Manufacturer Narrative

The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

It was initially reported that the pump switched from pca to continuous mode during delivery of morphine.Report was later corrected to state that the pump was not switching on its own but was incorrectly programmed due to user error.The patient did pass away some hours later.Coroner's investigation has not been provided.

Manufacturer Narrative

Pump was returned for evaluation.Visual inspection of the pump revealed it to be in good condition.Event history log was reviewed and showed that the delivery model was changed and acknowledged by the operator of the pump at the time.Unable to duplicate any delivery or programming issues with the pump.Pump performed as intended.

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5062038
• MDR Text Key: 25194890
• Report Number: 2183502-2015-00648
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Pharmacist
• Report Date: 09/08/2015

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 Model Number: 2100
• Device Catalogue Number: 21-2120-0100-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2011
• 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): Death