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

Model Number 2111

Device Problems Inaccurate Delivery (2339); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that during use of this infusion pump to administer morphine for pain, the patient was able to determine the programming codes (source of information not provided at this time).The reporter stated the patient used the "prime" function to deliver additional morphine 4 times.Additional information has been requested regarding patient status and how the programming codes were obtained.The reporter stated "a serious morphine overdose" was observed.At this time no details of the patient treatment have been provided.No permanent adverse effects reported.

• Brand Name: CADD-SOLIS HPCA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane n; minneapolis, MN 55442
• MDR Report Key: 7939003
• MDR Text Key: 122849707
• Report Number: 3012307300-2018-04184
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2018

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: Lay User/Patient
• Device Model Number: 2111
• Device Catalogue Number: 21-2111-0300-02
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2015
• 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): Other