OUTLOOK

Report

Report Number: 1641965-2012-00038
Event Type: Injury
Date Received: November 2, 2012
Date of Event: October 9, 2012
Report Date: October 22, 2012
Manufacturer: B. BRAUN MEDICAL, INC.
Product Code: FRN
PMA / PMN Number: K011975
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: VA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION RESULTS: THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE PUMP WAS RECEIVED, VISUAL INSPECTION REVEAL NO PHYSICAL DAMAGE OR ANOMALIES. THE OPERATIONAL LOG DID NOT HAVE ANY USEFUL DATA REGARDING THE REPORTED EVENT, PER BIOMED THE PUMP WAS UPGRADED TO THE LATEST SOFTWARE UPDATE AFTER THE REPORTED EVENT AND THE LOG WAS CLEARED AS PART OF THE UPDATE. EVAL: PERFORMED TEST BY INDUCING ERROR, THE PUMP RESPONDED WITH A BACK-UP ALARM AND PROPER OPERATIONAL ALARM WAS DISPLAYED TO WARN USER AN ERROR HAD OCCURRED. RAN THE PUMP FOR 24 HOURS WITHOUT ALARMS OR INTERROGATIONS. ALSO, INSPECTED FOR LOOSE OR INTERMITTENT ELECTRICAL CONNECTIONS, BUT NO BAD CONNECTION WERE FOUND. TH E PUMP MET ALL TESTS REQUIREMENTS AND THE REPORTED EVENT COULD NOT BE DUPLICATED.

Description of Event or Problem · 1

(B)(6) (BABY IN NICU). DRUG: ELECTROLITES (BABY-LITES). LIMITED INJURY. MEDICAL INTERVENTION: DREW BLOOD TO MAKE SURE BABY'S LEVELS WERE OK - BABY FINE. DATE OCCURRED: (B)(6) 2012. SORT OF UNDERINFUSION AS DID NOT ALARM WHEN INFUSION STOPPED FOR NO REASON / THERAPY DELAYED WITHOUT AN ALARM. RAN FOR LESS THAN 1 HOUR AS CHECK NICU AT LEAST ONCE EVERY 1 HOUR. RETURN TO BIOMED / RATE SET AT 7 - VOL CONTINUOUS RATE CHANGES (25, 40, ETC. TO WHAT BABY NEEDED) PUMP STOPPED PUMPING WITH NO ALARM / ERROR ON PIGGYBACK SCREEN ONLY / NO AUDIBLE ALARM / RELATION SOLUTION PROBABLY 1/2 OF THE BAG CONTENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OUTLOOK	INFUSION PUMP	FRN	B. BRAUN MEDICAL, INC.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other