MAUDE Adverse Event Report: SMITHS MEDICAL CADD®-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Model Number 2110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Brain Injury (2219)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

User facility reported that after usage of a pump and medication cassette following ankle surgery, the patient experienced a cardiac arrest and severe brain damage.The patient had undergone surgery for trauma to an ankle on (b)(6) 2016.Post-operatively, the patient was placed on the pump, which had a cassette full of morphine sulfate.No complications were reported.The following morning, the patient suffered a cardiac arrest and was transferred to the intensive treatment unit (itu).It was also reported that the patient suffered severe brain damage.According to the technical devices manager at the user facility, it was stated that the pump operated as programmed.Additional information about the event and outcome have been requested.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information was received: according to the reporter, a 50ml cassette of morphine sulphate 100mg/50ml was used with the reported device.It was reported that a total of 15.5ml of morphine was infused between (b)(6) 2016; the patient had not been infused with any other morphine 24 hours prior to the reported event.The reporter stated that the device settings had been verified by two registered nurses.Additionally, the reporter stated that they had performed non-invasive testing on the device and found that the cassette weighed approximately 71.86g which was believed to be 19.93g less than a full cassette's weight; therefore, it was estimated 19.93ml had been delivered to the patient or used to prime the set.According to the reporter, the estimated amount, 19.93ml, was found to be in reasonable agreement with what was reported to be delivered by the pump or used for priming of the device.

Manufacturer Narrative

The reported cadd®-solis ambulatory infusion pump was returned for investigation.The device event history log was reviewed and it was observed that the device functioned normally and no anomalies were found.The device underwent several functional tests.The device accuracy was tested three times, all tests were found to be within manufacturing specification.The device downstream sensor was then tested three times; all tests passed manufacturing specification.Additionally, the device air detector, upstream sensor, ac adapter, and remote does cord were all found to pass manufacturing specification.Investigation determined that the device operated as intended and no fault was found.(b)(4).

• Brand Name: CADD®-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, 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 55112 ; 7633833052
• MDR Report Key: 5730975
• MDR Text Key: 47585821
• Report Number: 2183502-2016-01203
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: D263302
• 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,Followup,Followup
• Report Date: 05/20/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 2110
• Device Catalogue Number: 21-2111-0300-50
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2016; 11/16/2016; 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 71 YR