INFUSOMAT SPACE - US VERSION

Report

Report Number: 9610825-2011-00128
Event Type: Malfunction
Date Received: September 28, 2011
Date of Event: August 22, 2011
Report Date: September 28, 2011
Manufacturer: B. BRAUN MELSUNGEN AG
Product Code: FRN
PMA / PMN Number: K062700
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

EXEMPTION NUMBER (B)(4). B. BRAUN MEDICAL, INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN (B)(4)(THE MANUFACTURER), AND (B)(4) (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B.BRAUN (B)(4)INTERNAL REPORT (B)(4). B. BRAUN MEDICAL INC. FORMED A CROSS-FUNCTIONAL WORKING GROUP WITH MEMBERS FROM QUALITY, ENGINEERING, SERVICE, SALES, CLINICAL AND TECHNICAL SUPPORT AND PRODUCT MANAGEMENT WITH THE PURPOSE TO INVESTIGATE AND BRING RESOLUTION TO THE EVENTS REPORTED TO B. BRAUN FROM (B)(6) GENERAL HOSPITAL. B. BRAUN TOOK A THREE-PRONGED APPROACH TO THIS INVESTIGATION: CLINICAL ON-SIT ASSESSMENT, BIOMEDICAL ON-SITE ASSESSMENT - INCLUDED PREVENTATIVE MAINTENANCE AND REPAIRS AS NEEDED ON ALL PUMPS, CUSTOMER COMPLAINT INVESTIGATION. THE CLINICAL ON-SITE ASSESSMENT WAS CONDUCTED FROM (B)(6) 2011 BY B. BRAUN CLINICAL PERSONNEL. DURING THIS ASSESSMENT, ALL HOSPITAL SHIFTS WERE COVERED AND A TOTAL OF 118 CLINICIANS WERE INCLUDED FROM 14 DIFFERENT AREAS OF CARE. THIS ASSESSMENT REVEALED NO USER RELATED ISSUES THAT COULD HAVE LED TO THIS EVENT. THE PURPOSE OF THE BIOMEDICAL ON-SITE ASSESSMENT WAS TO PHYSICALLY INSPECTED ALL PUMPS WITHIN (B)(6) GENERAL HOSPITAL, REPAIR AS NEEDED AND CONDUCT PREVENTIVE MAINTENANCE ACTIVITIES AS DEFINED BY THE B. BRAUN INFUSOMAT SERVICE MANUAL. OVER THE COURSE OF 8.5 DAYS FROM (B)(6) 2011, B. BRAUN TECHNICAL SERVICE TECHNICIANS PERFORMED PREVENTIVE MAINTENANCE ON 578 PUMPS. WHILE 25 PUMPS (4%) WERE REPAIRED BASED ON THE FINDINGS OF THIS ASSESSMENT, IT HAS BEEN CONCLUDED THAT THE REASON FOR THESE REPAIRS COULD NOT HAVE CONTRIBUTED TO THIS EVENT OR ANY SIMILAR EVENTS. CUSTOMER COMPLAINT INVESTIGATION RESULTS: THE ACTUAL PUMP IN THE REPORTED INCIDENT WAS RETURNED FOR EVALUATION. A REVIEW OF THE PUMP LOG REVEALED THAT ON (B)(6) 2011 AT 3:13:13AM, THE PUMP'S PRIMARY RATE WAS SET TO 10ML/HR WITH A VTBI OF 100ML. THE INFUSION RAN FOR 128 MINUTES AND HAD AN ACTUAL VOLUME DELIVERED OF 21.32ML, OR 100.0% OF THE EXPECTED VOLUME. THE TUBING WAS REMOVED AND REPLACED. THE NEXT INFUSION STARTED AT 5:25:00AM AND CONTINUED FOR 15 MINUTES 48 SECONDS. THE ACTUAL VOLUME OF THIS INFUSION WAS 2.63ML, OR 98.5% OF THE EXPECTED VOLUME. THE PUMP WAS THEN SET TO RUN IN PIGGYBACK MODE, WITH A VTBI OF 50ML AND A RATE OF 150ML/HR. THE PUMP RAN FOR 20 MINUTES AS EXPECTED, DELIVERING 50ML BEFORE CHANGING BACK TO PRIMARY MODE. THE PUMP THEN RAN FOR ANOTHER 18 MINUTES IN PRIMARY BEFORE THE INFUSION WAS STOPPED MANUALLY. THE ACTUAL PRIMARY VOLUME DELIVERED WAS 2.93ML, OR 97.7% OF THE EXPECTED AMOUNT. THE VOLUMES INFUSED WERE ALL WITHIN THE SPECIFICATION OF 100 +/-5%. THE PUMP WAS SET AGAIN TO PIGGYBACK MODE; HOWEVER, THERE WERE NO SIGNIFICANT INFUSIONS IN THE LOG AFTER THE CHANGE - TWO INFUSIONS OF APPROXIMATELY 1.5 MINUTES EACH. PER THE LOG, THE PUMP RAN AS PROGRAMMED. THE PUMP WAS TESTED THREE TIMES FOR VOLUMETRIC ACCURACY IN PIGGYBACK MODE AT A RATE OF 150ML/HR AND A VTBI OF 50ML, WHICH IS CONSISTENT WITH THE PROGRAMMED RATE IN THE PUMP LOG DURING THE REPORTED EVENT. THE RESULTS WERE WITHIN SPECIFICATIONS AT 50.4ML, 50.4ML, AND 50.6ML. IN ADDITION, THERE WAS NO FREE FLOW CONDITION THAT COULD BE REPLICATED WITH THE DOOR OPEN OR CLOSED. THE REPORTED FAILURE COULD NOT BE REPRODUCED ON THE RETURNED PUMP. IN ADDITION TO THE TESTING THAT WAS CONDUCTED ON THE RETURNED PUMP, VARIOUS LOT NUMBERS OF INFUSOMAT SPACE PUMP IV TUBING SETS (B. BRAUN MATERIAL NUMBER (B)(4)) THAT WERE DISTRIBUTED TO (B)(6) GENERAL HOSPITAL WERE ALSO EVALUATED TO ELIMINATE THE SETS AS A POTENTIAL CONTRIBUTING FACTOR. THERE WERE NO VISUAL ANOMALIES IDENTIFIED AND ALL DIMENSIONS ANALYZED WERE WITHIN THE ESTABLISHED SPECIFICATIONS, INCLUDING THE SPACE TUBING SEGMENT OF THE SETS. THE TUBING SETS WERE ALSO TESTED ON A VARIETY OF INFUSOMAT SPACE PUMPS AT VARIOUS INFUSION RATES AND EACH OF THE SETS FUNCTIONED AS INTENDED. BASED ON THE RESULTS OF THIS INVESTIGATION, NO CONCLUSIONS CAN BE MADE REGARDING THE CAUSE OF THE EVENT. ALL AVAILABLE INFORMATION HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE FROM THE MANUFACTURER, A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem · 1

NIGHT SHIFT RN ATTEMPTING TO HANG AM KCL REPLACEMENT THROUGH SECONDARY SET PIGGYBACKED INTO PRIMARY MED LINE. DRIP RATE SET TO 150CC/HR, TURNED ON AND KCL SEEN AS FREE FLOWING. RN IMMEDIATELY TURNED OFF SECONDARY SET AND NOTIFIED NEFF, CC. NEFF ALSO WITNESSED FREE FLOW KCL, VERIFYING THAT KCL NOT BACK FLOWING INTO PRIMARY IV BAG. BRAUN PUMP CHANGED OUT AND FREE FLOW ISSUE RESOLVED AND ABLE TO CONFIRM THAT DRIP RUNNING AT SET RATE. PUMP SEQUESTERED, PRIMARY IV TUBING PULLED WITH LOT NUMBER AND TAKEN TO BIOMED. ADDITIONAL INFORMATION RECEIVED INDICATES RN WENT TO HANG A KCL PIGGYBACK 50ML CONNECTED TO THE PRIMARY IV LINE WHICH WAS AT A RATE OF 10ML/HR. SET THE LIBRARY TO PIGGYBACK AT A RATE OF 150ML/HR. OPENED THE SECONDARY CLAMP AND NOTED FREE FLOW OF KCL; IMMEDIATELY CLAMPED OFF THE SECONDARY LINE AND CHECK PRIMARY BAG AND THERE DIDN'T APPEAR TO BE ANY RETROGRADE INTO THE PRIMARY BAG. DECIDED TO ADD A VOLUTROL TO PRIMARY LINE TO MONITOR IF ANY RETROGRADE WAS OCCURRING. SET PIGGYBACK TO DELIVER 30ML (AS A PRECAUTION), OPENED SECONDARY CLAMP AND FREE FLOW OF KCL HAPPENED AGAIN. NO RETROGRADE FLUID APPEARED IN VOLUTROL. IMMEDIATELY CLAMPED SECONDARY LINE. CHANGED OUT PUMPS AND FREE FLOW PROBLEM DISAPPEARED USING THE SAME IV TUBING. THERE WAS NO HARM TO THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFUSOMAT SPACE - US VERSION	INFUSION PUMP	FRN	B. BRAUN MELSUNGEN AG	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other