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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL CADD®-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
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).
 
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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 Key5730975
MDR Text Key47585821
Report Number2183502-2016-01203
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
D263302
Number of Events Reported1
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 Number2110
Device Catalogue Number21-2111-0300-50
Device Lot NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2016
Initial Date FDA Received06/16/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received11/16/2016
11/16/2016
11/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Disability;
Patient Age71 YR
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