MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD CADD® CADD-LEGACY® PCA PUMP; PUMP, INFUSION, PCA

Model Number 6300

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock (2072)

Event Type  malfunction  

Manufacturer Narrative

Additional manufacturer narrative: smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.D10 clarification: the product was received on (b)(6) 2016, however, was not inspected until (b)(6) 2016 (hence the awareness date of (b)(6) 2016).

Event Description

Device distributor reported on behalf of user that the device was in use and user received electric shock.No adverse health outcome was reported.

Manufacturer Narrative

The reported device was returned for evaluation.The device ac adaptor was not returned with the device.The pump's event history log was downloaded and examined; however the ehl cannot show whether patient was using device with ac adaptor or under battery power.Visual inspection found the device to be in good condition.During functional testing, no electrical abnormalities were observed.The reported issue (electrical shock during pump handling) could not be verified during investigation.Investigation and evaluation of the device was unable to determine the root cause of the electric shock.

• Brand Name: CADD® CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD; bramingham business park; enterprise way; luton, beds LU3 4 BU; UK LU3 4BU
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; bramingham business park; enterprise way; luton, beds LU3 4 BU; UK LU3 4BU
• Manufacturer Contact: lisa perz ; 1265 grey fox road; st paul 55112 ; 7633833074
• MDR Report Key: 5775122
• MDR Text Key: 48949272
• Report Number: 2183502-2016-01351
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1