Outlook® 375196Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964183034), received between Nov 21, 2016 and Sep 20, 2017 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: EVENT 2: OUTLOOK IV SET DETACHED FROM THE MIDDLE Y-SITE DURING AN INFUSION. PUMP WAS INFUSING NORMAL SALINE SOLUTION AT A KVO (KEEP VEIN OPEN) RATE. NURSE WALKED INTO PATIENTS ROOM AND NOTICED THE IV TUBING DETACHED AT THE MIDDLE OF THE Y-SITE. PATIENT'S BLOOD WAS BACKING UP INTO THE TUBING AND A PUDDLE OF FLUID AND BLOOD WAS NOTED ON THE FLOOR. IV INFUSION WAS STOPPED AND IV SITE WAS CAPPED. NO FURTHER INTERVENTION NEEDED. CUSTOMER STATED THIS IS THE SECOND TIME THE INCIDENT HAPPENED WITHIN A WEEK. NO INJURIES REPORTED. CUSTOMER REPORTS 3 POTENTIAL LOT NUMBERS IN THE FACILITY THAT COULD BE RELATED TO THE REPORTED EVENT. POTENTIAL LOT NUMBER: 0061557903, 0061546965, 0061559982.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6878946 ↗
• MalfunctionSep 20, 2017Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY THE USER FACILITY: OUTLOOK IV SET DETACHED FROM THE MIDDLE Y-SITE DURING AN INFUSION. PUMP WAS INFUSING NORMAL SALINE SOLUTION AT A KVO (KEEP VEIN OPEN) RATE. NURSE WALKED INTO PATIENTS ROOM AND NOTICED THE IV TUBING DETACHED AT THE MIDDLE OF THE Y-SITE. PATIENT'S BLOOD WAS BACKING UP INTO THE TUBING AND A PUDDLE OF FLUID AND BLOOD WAS NOTED ON THE FLOOR. IV INFUSION WAS STOPPED AND IV SITE WAS CAPPED. NO FURTHER INTERVENTION NEEDED. CUSTOMER STATED THIS IS THE SECOND TIME THE INCIDENT HAPPENED WITHIN A WEEK. NO INJURIES REPORTED. CUSTOMER REPORTS 3 POTENTIAL LOT NUMBERS IN THE FACILITY THAT COULD BE RELATED TO THE REPORTED EVENT. POTENTIAL LOT NUMBER: 0061557903, 0061546965, 0061559982.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6878943 ↗
• MalfunctionNov 21, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  AS REPORTED BY THE USER FACILITY: REPORTS THE PUMP ALARMS AIR IN LINE MULTIPLE TIMES. THE NURSES TRY TO RE-PRIME THE LINE, BUT PUMP CONTINUES TO ALARM FOR AIR IN LINE. UPON INSPECTION OF THE TUBING SET, A SMALL HOLE WAS OBSERVED NEAR THE METAL PUMP SEGMENT AND LEAKAGE WAS NOTED. ANTIBIOTIC MEDICATION WAS BEING INFUSED AT THE TIME. THE PATIENT DID NOT RECEIVE THE TOTAL DOSE AND WAS EXPOSED TO AIR IN LINE. ONCE THE TUBING WAS CHANGED, THERE WERE NO FURTHER AIR IN LINE ALARMS OR LEAKAGE THERE WERE NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6118063 ↗