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

Catalog Number 21-6300-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Overdose (1988)

Event Date 10/07/2016

Event Type  Injury  

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.(b)(4).

Event Description

It was reported that a cadd-legacy pca pump was involved in an oxynorm overinfusion incident.The infusion was programmed for 6 days but was observed that the cassette (100ml) was empty and infused into the patient after 48 hours.Troubleshooting involved testing the infusion system without patient involvement and showed that the system infused 3 times more than the programmed volume.The infusion system was tested with different cassettes and it was noted that the problem stopped.The cassette involved in the incident was retested without patient involvement and the observed incident did not occur again.Intravenous narcan was administered to decrease the oxynorm overinfusion effects.No permanent injury was reported.See mfr: 3012307300-2016-00360.

Manufacturer Narrative

One cadd-legacy® pca pump was returned for investigation.Visual inspection of the returned device found it to be in good condition.A review of the device event history log found that the device had delivered the volumes of medication as programmed by the clinician.Functional accuracy sensor testing were performed on the device.No discrepancies were found during testing and the device was found to be within specification for delivery accuracy and alarm sensors.Investigation did not find fault with the returned device and determined that it functioned as designed.

Event Description

It was further reported that the device was in use starting on (b)(6) 2016 and the reported event was observed on (b)(6) 2016.Additionally it was reported that the device was programmed at a rate of 0.1 ml/h with an allowed bolus rate of 0.25ml.

• Brand Name: CADD-LEGACY® PCA PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6103282
• MDR Text Key: 59965909
• Report Number: 3012307300-2016-00361
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-6300-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/24/2016
• Initial Date FDA Received: 11/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2006
• 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
• Treatment: CADD¿ MEDICATION CASSETTE WITH FLOW STOP
• Patient Outcome(s): Required Intervention