Alaris, SmartSite 10178573Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613203021111), received between Mar 4, 2019 and May 14, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ER PATIENT WAS INITIATED ON KETAMINE 8.5MG/100ML NS FOR PAIN MANAGEMENT IN THE CT ROOM. DURING THE CT SCAN THE TUBING LEAKED AT THE SILICONE SEGMENT OF THE TUBING AND SPRAYED THE WINDOW AND THE FLOOR. THE AMOUNT OF MEDICATION GIVEN WAS UNCERTAIN AS THE ENTIRE CONTENTS OF THE BAG WAS LOST AND THE PUMP WAS IMMEDIATELY TURNED OFF. THE PHARMACIST EXAMINED THE BAG AND LINE AND NOTED THAT THE IV LINE JUST BELOW THE SPIKE WHERE THE LINE WAS ATTACHED TO THE BAG HAD COMPLETELY 'BURST' AND WAS ABOUT 25% ATTACHED TO THE SPIKE AND THE BAG. THE PATIENT CONTINUED TO HAVE ESCALATING PAIN SO A SECOND DOSE WAS PREPARED, HOWEVER THE PAIN ESCALATED FURTHER AND ADDITIONAL INTERVENTION WAS REQUIRED. THE CUSTOMER STATED THE DEVICES WILL BE INVESTIGATED BY A THIRD PARTY COMPANY AND WILL NOT BE RETURNED. THERE WAS NO LASTING HARM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8607804 ↗
• MalfunctionMar 4, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTED AN ANTIBIOTIC WAS HUNG AS A SECONDARY INFUSION IN THE CCU. THE SECONDARY BAG WOULD ALTERNATE DRIPS WITH THE PRIMARY BAG, AND THE PATIENT WAS NOT GETTING THE ANTIBIOTICS AT THE CORRECT RATE, DESPITE USING A PUMP MODULE. A NEW PUMP MODULE WAS OBTAINED ALONG WITH NEW TUBING, AND THE SAME THING OCCURRED. THE CONNECTION BETWEEN THE PRIMARY AND NON-BD SECONDARY TUBING WAS CHECKED BY TWO NURSES, AND EVEN DISCONNECTED AND RECONNECTED FOR TROUBLESHOOTING. THE PRIMARY AND THE SECONDARY INFUSION HAD AN APPROPRIATE HEAD HEIGHT DIFFERENCE, AND THIS WAS ALSO ADJUSTED A FEW TIMES TO ENSURE THE CONCURRENT FLOW WAS NOT RELATED TO HEAD HEIGHT. AS A RESULT OF THE CONCURRENT FLOW, THE INFUSION TOOK LONGER THAN ORDERED. THE SECONDARY INFUSION IS THOUGHT TO HAVE BEEN LEVAQUIN, AND THE PRIMARY INFUSION WAS 0.9% NORMAL SALINE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8388317 ↗