MAUDE Adverse Event Report: SMITHS MEDICAL, INC. CADD AMBULATORY INFUSION PUMP; PUMP, INFUSION

Device Problem Programming Issue (3014)

Patient Problem Overdose (1988)

Event Type  Injury  

Event Description

Report received via an article from the institute for safe medical practices (attached) that a patient received 4,500 mg of fluorouracil iv within 2 hours of starting which was supposed to be infused over 46 hours.The pump was found to have been programmed incorrectly, delivering meds in 2 hours verses 2 days.Patient was admitted to the hospital due to toxic side effects including thrombocytopenia, myelosuppression, mucositis, edema of hands and feet, arrhythmia, severe asthenia and gastrointestinal effects.Patient was hospitalized for 2 weeks for treatment of the overdose side effects before being discharged home.No permanent adverse health outcome reported.

Manufacturer Narrative

(b)(4).Additional 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.

• Brand Name: CADD AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): SMITHS MEDICAL, INC.; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: michele seliga ; 1265 grey fox rd; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 4926032
• MDR Text Key: 6431014
• Report Number: 2183502-2015-00519
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Home Health Aide
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention