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

Model Number 6300

Device Problem Programming Issue (3014)

Patient Problem Death (1802)

Event Date 11/24/2015

Event Type  Death  

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.

Event Description

Report received from (b)(6) stated that the pump was in use with female cancer patient for administration of morphine.According to the report, the patient was determined beyond treatment and was scheduled to be released from hospital care on (b)(6) 2015.At that time, the patient's physician ordered the patient begin infusion of morphine via ambulatory infusion pump.The pump was provided by a distributor ((b)(4)) with the physician's prescribed delivery rate already programmed into the pump (the physician prescribed dosage of 2.8mg morphine/per hour).The patient received the pump and began infusion of morphine on (b)(6) 2015 at 10:15am.Later in the day of (b)(6) 2015, the patient's condition began to deteriorate.At that time, the pump's settings were reviewed and it was found that the delivery rate was not set correctly.The pump was reported to be set to be set to deliver 150mg instead of 67mg.The patient passed away on (b)(6) 2015 at 2:50am.

Manufacturer Narrative

The reported pump, cadd-legacy pca, model 6300, (b)(4) was returned for investigation.The complaint details that the patient death occurred on (b)(6) 2015 at 2:50 am.The patient was put on the pump on (b)(6) 2015 and the pump should have been programmed with a delivery rate of 2.8 mg/hr at this time.Inspection of the pumps event history log shows that the pumps was programmed at 09:07:00 on (b)(6) 2015 with a delivery rate of 3.10 mg/hr with a concentration of 5.0 mg/ml.Immediately after this the pumps programmed was changed and the delivery rate was set to 2.80 ml/hr with a demand dose set to 0.40 ml.The pump was started and stopped immediately with these programmed values.The pumps rate was then changed to 1.00 ml/hr at 19:01:00 on (b)(6) 2015 and the pump was started and ran 15 minutes until 19:16:00 with this programmed rate.The pump at this time was then stopped.The pump was then turned off the next day (b)(6) 2015 at 03:36:00.The pumps event log indicates that the pump delivery rate was programmed in milliliters instead of milligrams.An equivalent for a 2.8 mg/hr rate in milliliters would be 0.0028 ml/hr.The pump was programmed to deliver 1.0 ml/hr.The pumps event log was changed from german to english and the occurrence of those events were verified.The event log did not show any unusual messages or events taking place at this time and indicated the pump was delivering properly and as programmed.Delivery accuracy tests were performed on the pump and the pump was found to be delivering properly and within specification.The pump passed all tests and was found to be operating properly.The fault could not be confirmed.

• Brand Name: CADD-LEGACY PCA INFUSION PUMP
• Type of Device: INFUSION PUMP, PCA
• Manufacturer (Section D): SMITHS MEDICAL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox road; st. paul, MN 55112 ; 7633833052
• MDR Report Key: 5696249
• MDR Text Key: 46462323
• Report Number: 2183502-2016-01153
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6300
• Device Catalogue Number: 21-6300-03
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death