Outlook® US3130Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964188015), received between Nov 14, 2017 and Nov 14, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Infusion or Flow Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2017Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 4: END USER REPORTS THAT THEY HAD 2 X EACHES OF THE TEVADAPTOR SPIKE PORT ADAPTOR (B)(4), LOT NUMBER UA3013A USED WITH AN OUTLOOK PRIMARY IV SET (B)(4) (UNKNOWN LOT NUMBER) THAT ARE HAVING BUBBLES DEVELOP IN LINE DURING INFUSION. THE REPORTER STATED THE BUBBLES ARE NOT NOTED IN LINE UNTIL APPROXIMATELY 95 PERCENT OF THE INFUSION IS INFUSED. THE OUTLOOK PUMP ALARMS "CHECK SET ALARM". WHEN NURSE CHECKS THE SET, THERE ARE SEVERAL BUBBLES FOUND IN THE IV SET IN THE CASSETTE ASPECT. THE NURSE THEN AT THAT POINT HAS TO DETACH IV SET FROM PATIENT AND PATIENT DOES NOT GET REMAINING DOSE. THE PUMP SET IS DETACHED PRIOR TO AIR IN LINE REACHING THE PATIENT. CUSTOMER IS NEW TO THE TEVA ONGUARD PRODUCT SPIKE ADAPTOR, BEEN USING FOR ABOUT 2 MONTHS. THE BUBBLES IN LINE HAVE HAPPENED ABOUT 4 TIMES OVERALL, THESE ARE THE ONLY TWO SETS SAVED. BBRAUN SALES REP PROVIDED TRAINING ON SITE TO STAFF AND INSTRUCTIONS FOR USE AND SUPPORTIVE LITERATURE AND VIDEOS ARE AVAILABLE TO THE CLINICIANS. THE CUSTOMER STATED THEY USE THE IFU AND PACKAGE INSERT PRIOR TO USE. LIMITED INFORMATION PROVIDED, NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029524 ↗
• MalfunctionNov 14, 2017Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 1: IT WAS CONFIRMED THAT THE PHARMACIST PREPARES THE IV SET REF NUMBER US3130 WITH THE TEVA SPIKE ADAPTOR REF NUMBER 412113 WITH THE IV SOLUTION REFERENCE NUMBER L8002. ONE OF THE EACHES IS WITH CARBOPLATIN (CHEMO AGENT) AND THE OTHER OF THE EACHES REPORTED IS WITH GEMCITABINE (CHEMO AGENT) UNDER THE HOOD. BOTH IV BAGS WERE FOR THE SAME PATIENT A (B)(6) MALE, WEIGHING (B)(6) KG. ONCE THE PHARMACIST PREPARES THE CHEMO, SODIUM CHLORIDE, SPIKE ADAPTOR AND PRIMARY IV SET, SHE PRIMES THE SETS AND THEN SENDS TO THE NURSING UNIT. THE NURSE FIRST PROGRAMMED THE GEMCITABINE AT RATE OF 600 CC/HOUR, STARTED INFUSION. NO BUBBLES IN THE LINE AT TIME OF INFUSION STARTED. THE INFUSION CONTINUED FOR ABOUT 95 PERCENT OF THE BAG, THEN THE PUMP ALARMED "CHECK SET", THE NURSE CHECKED THE IV SET AND NOTICED AN ACCUMULATION OF BUBBLES IN THE CASSETTE ASPECT OF THE IV TUBING. NURSE DETACHED IV SET FROM PATIENT. THE PATIENT DID NOT RECEIVE REMAINDER OF DOSE TO BE INFUSED. THE REPORT STATED THAT THE VOLUME OF DRUG THAT THE PATIENT DID NOT RECEIVE WERE SO MINUTE, THE PATIENT WOULD NOT HAVE ILL EFFECTS FROM IT. (JUST IN 1 AND 2) THE PATIENT HAD NO INJURIES REPORTED. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029522 ↗
• MalfunctionNov 14, 2017Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 3: END USER REPORTS THAT THEY HAD 2 X EACH OF THE TEVADAPTOR SPIKE PORT ADAPTOR REFERENCE NUMBER (B)(4), LOT NUMBER UA3013A USED WITH AN OUTLOOK PRIMARY IV SET REFERENCE NUMBER US3130 ( UNKNOWN LOT NUMBER) THAT ARE HAVING BUBBLES DEVELOP IN LINE DURING INFUSION. THE REPORTER STATED THE BUBBLES ARE NOT NOTED IN LINE UNTIL APPROXIMATELY 95 PERCENT OF THE INFUSION IS INFUSED. THE OUTLOOK PUMP ALARMS "CHECK SET ALARM". WHEN NURSE CHECKS THE SET, THERE ARE SEVERAL BUBBLES FOUND IN THE IV SET IN THE CASSETTE ASPECT. THE NURSE THEN AT THAT POINT HAS TO DETACH IV SET FROM PATIENT AND PATIENT DOES NOT GET REMAINING DOSE. THE PUMP SET IS DETACHED PRIOR TO AIR IN LINE REACHING THE PATIENT. CUSTOMER IS NEW TO THE TEVA ONGUARD PRODUCT SPIKE ADAPTOR, BEEN USING FOR ABOUT 2 MONTHS. THE BUBBLES IN LINE HAVE HAPPENED ABOUT 4 TIMES OVERALL, THESE ARE THE ONLY TWO SETS SAVED. BBRAUN SALES REP PROVIDED TRAINING ON SITE TO STAFF AND INSTRUCTIONS FOR USE AND SUPPORTIVE LITERATURE AND VIDEOS ARE AVAILABLE TO THE CLINICIANS. THE CUSTOMER STATED THEY USE THE IFU AND PACKAGE INSERT PRIOR TO USE. LIMITED INFORMATION PROVIDED, NO INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029518 ↗
• MalfunctionNov 14, 2017Infusion or Flow Problem; Infusion or Flow Problem

  AS REPORTED BY THE USER FACILITY: EVENT 2: IT WAS CONFIRMED THAT THE PHARMACIST PREPARES THE IV SET REF NUMBER US3130 WITH THE TEVA SPIKE ADAPTOR REF NUMBER 412113 WITH THE IV SOLUTION REFERENCE NUMBER L8002. ONE OF THE EACHES IS WITH CARBOPLATIN (CHEMO AGENT) AND THE OTHER OF THE EACHES REPORTED IS WITH GEMCITABINE (CHEMO AGENT) UNDER THE HOOD. BOTH IV BAGS WERE FOR THE SAME PATIENT A (B)(6) MALE, WEIGHING (B)(6) KG. ONCE THE PHARMACIST PREPARES THE CHEMO, SODIUM CHLORIDE, SPIKE ADAPTOR AND PRIMARY IV SET, SHE PRIMES THE SETS AND THEN SENDS TO THE NURSING UNIT. THE PATIENT THEN WAS TO RECEIVE THE SECOND DRUG CARBOPLATIN, THE SAME PROCESS. THE PHARMACIST PREPARED UNDER THE HOOD AND PRIMED AND THEN SENT ASSEMBLED IV SET TO THE NURSING UNIT. THE NURSE PROGRAMMED CARBOPLATIN AT 300 CC AND HOUR. THE SAME THING HAPPENED. NO BUBBLES NOTED IN SET PRIOR TO INFUSION. ABOUT 95 PERCENT INTO INFUSION, THE PUMP ALARM WENT OFF STATING "CHECK SET". NURSE REMOVED THE IV SET AND PATIENT DID NOT RECEIVE REMAINDER OF DOSE. THE REPORT STATED THAT THE VOLUME OF DRUG THAT THE PATIENT DID NOT RECEIVE WERE SO MINUTE, THE PATIENT WOULD NOT HAVE ILL EFFECTS FROM IT. THE PATIENT HAD NO INJURIES REPORTED. NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7029507 ↗