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MedStream Programmable Infusion Pump: Class 1 Recall - Malfunction In The Fill Level Sensor

Wednesday, July 24, 2013

AUDIENCE: Health Professional, Risk Manager

ISSUE: The Fill Level Sensor (FLS), a component of the Medstream Programmable Infusion Pump, may malfunction. The Fill Level Sensor is intended to measure the contents of the pump drug reservoir. The malfunction in the Fill Level Sensor may cause the pump’s low reservoir alarm, normally set at 3 ml, to sound too early or too late.

BACKGROUND: These affected products were distributed from July, 2009 through June, 2013 and include Models 91-4200US 20 ml pump, .91-4201US 40 ml pump, 91-4200 20 ml pump, 91-4201 40 ml pump

RECOMMENDATION: On June 07, 2013, Codman issued a Medical Device Corrections Notice1 2 to consignees to inform them of a potential problem with the MedStream Programmable Infusion Pump. The notice directed clinicians to evaluate the accuracy of the Fill Level Sensor, during each patient’s next scheduled refill session, or sooner if the patient is symptomatic. The firm provided a worksheet (step by step instructions) to identify pumps with a miscalibrated Fill Level Sensor and management recommendations for patients with affected devices. No action for physicians is required beyond the recommendations provided in the Medical Device Corrections Notification letter.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362038.htm

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