MAUDE Adverse Event Report: SMITHS MEDICAL CADD(R) SOLISAMBULATORY INFUSION KIT; PUMP, INFUSION PCA

Model Number 21-2101

Device Problem Device Operational Issue (2914)

Patient Problem Overdose (1988)

Event Type  Injury  

Manufacturer Narrative

The user facility has not returned the device to the manfuacturer for evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the investigation results.

Event Description

Per voluntary mdr (mw5043388), the user facility reported that the listed pump was in use with a patient sometime between (b)(6) 2015 and (b)(6) 2015 when the patient was overinfused with pain medication.The medication was reportedly 5x morphine or 10x hydromorphone.The cause of the overinfusion was reportedly due to the nurse having difficulty reading the pump's menu.In this case, the nurse failed to changed the medication concentration on the pump when changing pump cassette.The reporter explained that the user's eye is not drawn to the medication concentration selection located on the far right of the pump menu.

• Brand Name: CADD(R) SOLISAMBULATORY INFUSION KIT
• Type of Device: PUMP, INFUSION PCA
• Manufacturer (Section D): SMITHS MEDICAL; 1265 grey fox road; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5036178
• MDR Text Key: 24346054
• Report Number: 2183502-2015-00612
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• PMA/PMN Number: K072144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Report Date: 08/27/2015

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: Nurse
• Device Model Number: 21-2101
• Device Catalogue Number: 21-2101-51
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention