GEM V/NV 20D 1CV 2SS DEHP FREE
Report
- Report Number
- 9616066-2024-00716
- Event Type
- Malfunction
- Date Received
- May 13, 2024
- Date of Event
- April 16, 2024
- Report Date
- May 21, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- UDI-DI
- 07613203021012
- PMA / PMN Number
- K221327
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.
INVESTIGATION AND DHR (POTENTIAL LOTS) THE CUSTOMER REPORTED TROUBLE WITH A PRIMARY/SECONDARY SET UP, AND RETURNED BOTH SETS, WITH THE ISSUE REPORTED ON PRIMARY SET MATERIAL 2420-0007. THE SETS WERE VISUALLY EXAMINED, AND NO ISSUES WERE OBSERVED. THEN THE SETS WERE SET UP WITH TAP WATER ON THE PRIMARY, AND BLUE DYED WATER ON THE SECONDARY. THE ISSUE OF BACK CHECK VALVE ISSUE WAS ABOUT TO BE REPLICATED AND COMPLAINT CONFIRMED. THE SUPPLIER WAS NOTIFIED OF THE BACK CHECK VALVE FAILURE, AND SAMPLE WAS SENT FOR FURTHER TESTING. THE SUPPLIER INVESTIGATION WAS UNABLE TO REPLICATE THE BACK CHECK VALVE FAILURE, SO NO ACTIONS WERE TAKEN. THE ROOT CAUSE IS UNKNOWN WITHOUT A CONFIRMED FAILURE AT THE MANUFACTURING LOCATION. DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 24015098 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 08JAN2024. DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 24015219 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 11JAN2024. DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 24015339 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 16JAN2024. DEVICE HISTORY RECORD REVIEW FOR MODEL 2420-0007 LOT NUMBER 24015379 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 17JAN2024. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR ANY OF THE POTENTIAL LOTS FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT.
MATERIAL #: 2420-0007 BATCH#: 23115271 IT WAS REPORTED BY CUSTOMER THAT STAFF HUNG IV MED WITH A SECONDARY LINE AND FILTER IV TUBING AS PER PROTOCOL. OTHER RN WENT TO CHECK MEDICATION AND IMMEDIATELY NOTED THAT THE MEDICATION IV BAG WAS RUNNING WIDE OPEN EVEN THOUGH SETTINGS ON PUMP WERE CORRECT AND THE PRIMARY BAG BECAME VERY FULL, NOTED TO INCREASE IN SIZE RELATED TO THE VOLUME OF FLUID IN THE SECONDARY IV MED BAG. THE INFUSION WAS IMMEDIATELY STOPPED AND DISCONTINUED; MED NEEDED TO BE REMADE BY PHARMACY. THE LINES ARE PRIMED THE NIGHT BEFORE IN CANCER CARE, AND AS SUCH WE WERE NOT ABLE TO KEEP THE PACKAGING THE TUBING CAME IN. INSPECTION/PM PROCEDURE FOR BOTH DEVICES INVOLVED PASSED. BIOMED IS CONFIDENT THAT THIS IS A BACK-CHECK VALVE FAILURE AND THAT THE PUMP IS NOT AT FAULT AND IS OPERATING CORRECTLY. PRODUCT NUMBER - 2420-0007. Q: WHAT IS THE PRODUCT CODE ASSOCIATED WITH THE REPORTED BACK CHECK VALVE FAILURE? A: 2420-0007 Q: IS THE LOT NUMBER FOR THIS PRODUCT KNOWN? A: PROBABLY (10)23115271 Q: IS THE INCIDENT SAMPLE AVAILABLE FOR RETURN? A: YES. CONTAINS HAZARDOUS MEDICATION. Q: WAS THERE ANY HARM OR IMPACT TO THE PATIENT? PLEASE BE SPECIFIC A: MEDICATION WAS NOTICED TO NOT BE INFUSING AND THUS STOPPED RIGHT AWAY. BUT MEDICATION HAD TO BE RE-MADE BY PHARMACY WHICH TOOK SOME TIME AND PATIENT¿S TREATMENT WAS DELAYED BUT GIVEN THAT DAY. Q: HOW WAS TREATMENT COMPLETED FOR THE PATIENT? A: TREATMENT WAS DELAYED BUT COMPLETED THAT DAY Q: WHAT MEDICATIONS WERE BEING INFUSED WHEN THE INCIDENT OCCURRED? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) Q: WHAT WAS THE NAME OF THE MEDICATION/FLUID THAT OVER/UNDER INFUSED? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) Q: WAS THIS A "STAT" MEDICATION OR A ROUTINE ORDER? A: ROUTINE ORDER Q: WHAT WAS THE INTENDED VOLUME TO BE INFUSED (VTBI)? A: 84 MLS Q: WHAT WAS THE TOTAL BAG/BOTTLE VOLUME AND CONCENTRATION? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) PRIMARY BAG: 250ML NACL 0.9% Q: ARE THERE ANY OTHER INFUSIONS CURRENTLY RUNNING AT THE TIME OF THE EVENT? A: NO Q: IF SO, PLEASE LIST THE FLUIDS/MEDICATION (NAME AND RATE OF INFUSION): A: N/A Q: HOW WAS THE MEDICATION/FLUID PROGRAMMED INTO THE PUMP? A: MANUALLY, USING GUARDRAILS DRUG LIBRARY Q: HOW WAS TREATMENT COMPLETED FOR THE PATIENT? A: MEDICATION HAD TO BE RE-MADE BY PHARMACY AND THEN WAS GIVEN LATER THAT DAY I HAVE ATTACHED THE ERROR LOGS AND GUARDRAILS LIBRARY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. EVENT DESCRIPTION: STAFF HUNG IV MED WITH A SECONDARY LINE AND FILTER IV TUBING AS PER PROTOCOL. OTHER RN WENT TO CHECK MEDICATION AND IMMEDIATELY NOTED THAT THE MEDICATION IV BAG WAS RUNNING WIDE OPEN EVEN THOUGH SETTINGS ON PUMP WERE CORRECT AND THE PRIMARY BAG BECAME VERY FULL, NOTED TO INCREASE IN SIZE RELATED TO THE VOLUME OF FLUID IN THE SECONDARY IV MED BAG. THE INFUSION WAS IMMEDIATELY STOPPED AND DISCONTINUED, MED NEEDED TO BE REMADE BY PHARMACY. THE LINES ARE PRIMED THE NIGHT BEFORE IN CANCER CARE, AND AS SUCH WE WERE NOT ABLE TO KEEP THE PACKAGING THE TUBING CAME IN. INSPECTION/PM PROCEDURE FOR BOTH DEVICES INVOLVED PASSED. BIOMED IS CONFIDENT THAT THIS IS A BACK-CHECK VALVE FAILURE AND THAT THE PUMP IS NOT AT FAULT AND IS OPERATING CORRECTLY. PRODUCT NUMBER - 2420-0007. Q: WHAT IS THE PRODUCT CODE ASSOCIATED WITH THE REPORTED BACK CHECK VALVE FAILURE? A: 2420-0007 Q: IS THE LOT NUMBER FOR THIS PRODUCT KNOWN? A: PROBABLY (10)23115271 Q: IS THE INCIDENT SAMPLE AVAILABLE FOR RETURN? A: YES. CONTAINS HAZARDOUS MEDICATION. Q: WAS THERE ANY HARM OR IMPACT TO THE PATIENT? PLEASE BE SPECIFIC A: MEDICATION WAS NOTICED TO NOT BE INFUSING AND THUS STOPPED RIGHT AWAY. BUT MEDICATION HAD TO BE RE-MADE BY PHARMACY WHICH TOOK SOME TIME AND PATIENT¿S TREATMENT WAS DELAYED BUT GIVEN THAT DAY. Q: HOW WAS TREATMENT COMPLETED FOR THE PATIENT? A: TREATMENT WAS DELAYED BUT COMPLETED THAT DAY Q: WHAT MEDICATIONS WERE BEING INFUSED WHEN THE INCIDENT OCCURRED? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) Q: WHAT WAS THE NAME OF THE MEDICATION/FLUID THAT OVER/UNDER INFUSED? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) Q: WAS THIS A "STAT" MEDICATION OR A ROUTINE ORDER? A: ROUTINE ORDER Q: WHAT WAS THE INTENDED VOLUME TO BE INFUSED (VTBI)? A: 84 MLS Q: WHAT WAS THE TOTAL BAG/BOTTLE VOLUME AND CONCENTRATION? A: NIVOLUMAB (190MG/19ML + 50ML NORMAL SALINE, TOTAL: 69ML) PRIMARY BAG: 250ML NACL 0.9% Q: ARE THERE ANY OTHER INFUSIONS CURRENTLY RUNNING AT THE TIME OF THE EVENT? A: NO Q: IF SO, PLEASE LIST THE FLUIDS/MEDICATION (NAME AND RATE OF INFUSION): A: N/A Q: HOW WAS THE MEDICATION/FLUID PROGRAMMED INTO THE PUMP? A: MANUALLY, USING GUARDRAILS DRUG LIBRARY Q: HOW WAS TREATMENT COMPLETED FOR THE PATIENT? A: MEDICATION HAD TO BE RE-MADE BY PHARMACY AND THEN WAS GIVEN LATER THAT DAY I HAVE ATTACHED THE ERROR LOGS AND GUARDRAILS LIBRARY. THANKS! (B)(6) BIOMEDICAL ENGINEERING TECHNOLOGIST (B)(6) HOSPITAL (B)(6) PHONE: (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 846412 | GEM V/NV 20D 1CV 2SS DEHP FREE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON | UNKNOWN | 07613203021012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |