ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-250401
- Event Type
- Malfunction
- Date Received
- December 15, 2023
- Date of Event
- November 21, 2023
- Report Date
- September 25, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403811043
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
- Health Professional
- Yes
Narratives
A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE REPAIRED OR THE DEVICE/LOGS BE RECEIVED FOR EVALUATION. PER 803.52(F)(11)(III) THE INFORMATION PROVIDED REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. THE COMPLAINANT OR REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO THE MANUFACTURER. H3 OTHER TEXT : DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.
OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX A, G, B, C, D CODES AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD REVIEW IS PERFORMED ON EACH DEVICE REPORTED IN A MDR REPORTABLE EVENT ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.
INVESTIGATION SUMMARY: THE REPORTED COMPLAINT OF BLOOD BACKING UP DURING AN INFUSION OF FRESH FROZEN PLASMA (FFP) WAS CONFIRMED THROUGH INSPECTION, IDENTIFYING THE LACK OF A CHECK VALVE AND ANTI-SIPHON VALVE OF THE RETURNED ADMINISTRATION SETS AND LABORATORY TESTING. LABORATORY TESTING OF THE RETURNED ADMINISTRATION SETS CONFIRMED THE SETS EXHIBITING BACKFLOW. INSPECTION OF THE RETURNED ADMINISTRATION SETS FOUND THE SETS WERE MANUFACTURED BY AN UNAPPROVED NON-BD THIRD PARTY AND ONE (1) ROLLER CLAMP WAS OBSERVED WITH THE ROLLER PART NOT SEATED PROPERLY WITHIN THE HOUSING. DISPOSABLE FILE PR# 9322477 WAS OPENED TO INVESTIGATE THE DISPOSABLE SETS. PRIOR TO DCHU INVESTIGATION, BD CLINICAL PRACTICE CONSULTANT DETERMINED THAT THE POTENTIAL CONTRIBUTING FACTORS WAS DUE TO USE OF TUBING SETS THAT DO NOT HAVE ADDITIONAL COMPONENTS SUCH AS CHECK VALVES AND ANTI-SIPHON VALVES, WHICH PREVENTS BLOOD BACKING UP THE LINE (IN ADDITION TO THE ROLLER CLAMP/PINCH CLAMP). ADDITIONAL CONTRIBUTING FACTORS WERE NOTED AS: THE PUMP WAS REPORTEDLY SET-UP HIGHER THAN THE PATIENT (THE ¿PUMP SELECT¿ KEY SHOULD BE POSITIONED LEVEL WITH THE PATIENT'S HEART). THE UMBILICAL ARTERIAL LINE BECAUSE THERE WILL BE MORE BACK PRESSURE WITH AN ARTERIAL LINE. LABORATORY TESTING OF THE SYRINGE MODULE SHOWED THE DEVICE WAS OPERATING WITHIN SPECIFICATION. EXTERNAL AND INTERNAL INSPECTION OF THE SYRINGE MODULE FOUND INCIDENTAL FINDINGS ONLY WITH NO RELATION TO THE REPORTED COMPLAINT. REVIEW OF THE PCU EVENT LOG SHOWED, ON (B)(6) 2023 AT 12:46 PM, THE SUSPECT SYRINGE MODULE WAS SELECTED AND PROGRAMMED A BD 30ML SYRINGE (AVAILABLE VOLUME= 11.1799 ML) OF BLOOD PRODUCT (DRUGID=35) TO INFUSE AT A RATE OF 5 ML/HR (VTBI= 5 ML). APPROXIMATELY FIVE (5) MINUTES AFTER THE START OF INFUSION, THE SYRINGE MODULE WAS PAUSED AND A NEW BD30ML SYRINGE OF BLOOD PRODUCT (DRUGID=35; AVAILABLE VOLUME= 24.5882 ML) WAS LOADED INTO THE SYRINGE MODULE AND THE INFUSION WAS RESTORED (RATE= 5 ML/HR). THE INFUSION SUCCESSFULLY COMPLETED AND TRANSITIONED TO KVO (RATE= 1 ML/HR) BEFORE THE SYRINGE MODULE WAS CHANNELED OFF. REVIEW OF THE PCU ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. REVIEW OF THE LOGS COULD NOT DETERMINE THE VOLUME IN THE SYRINGE AT THE END OF INFUSION. USE OF REPAIR OR SERVICE PARTS, ACCESSORIES, OR SYRINGES, DEDICATED INFUSION SETS, OR DISPOSABLES THAT ARE NOT APPROVED BY BD IS AT CUSTOMER'S OWN RISK AND COULD EXPOSE PATIENTS TO RISK OF DEVICE FAILURE, INJURY, OR EVEN DEATH. A LIST OF BD APPROVED DISPOSABLES THAT ARE VALIDATED TO BE COMPATIBLE WITH THE BD ALARIS¿ SYSTEM IS PROVIDED IN THE BD ALARIS¿ SYSTEM USER MANUAL. THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE PROBABLE CAUSE OF THE COMPLAINT OF BLOOD BACKING UP IS BEING ATTRIBUTED TO THE USE OF UNAPPROVED NON-BD DISPOSABLE SETS THAT DO NOT HAVE ADDITIONAL COMPONENTS SUCH AS CHECK VALVES AND ANTI-SIPHON VALVES, WHICH PREVENTS BLOOD BACKING UP THE LINE. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G02017, G04037, C23, C0601, D11, D15 CODES NOT ASSOCIATED WITH THE REPORTED EVENT BUT IDENTIFIED AS REPORTABLE MALFUNCTIONS OBSERVED ON THE DEVICE DURING INVESTIGATION ARE UNRELATED TO THE REPORTED ISSUE. THESE OTHER FAILURES PRESUMPTIVELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE.
IT WAS REPORTED THAT AN ORDER WAS RECEIVED TO ADMINISTER FRESH FROZEN PLASMA (FFP) VIA UMBILICAL ARTERIAL CATHETER (UAC). PER REPORT, THE HOSPITAL PROTOCOL DICTATES THAT THE BLOOD COMPONENT SET IS 48 INCHES NEONATAL WITH 170 MICRONS FILTER PRIMED AND SET UP WITH SYRINGE WITH EXTRA BLUE CLAMP APPLIED IN ADDITION TO ROLLER CLAMP BEING CLOSED, AS PER UNITS PRACTICE CHANGE. THE SYRINGE USED WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT CALLED "ZOOMCO P.M.P./C.M.P. T-152248 (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." WHEN ATTACHING TO UAC, AND PUMP STARTED 5MLS OVER 1 HOUR PER ORDER. HOWEVER, IT WAS QUICKLY NOTED THAT BLOOD WAS FLOWING BACK OUT OF BABY AND INTO THE TUBING. TRANSFUSION STOPPED AND TUBING CLAMPED, AND UAC FLUSHED TO DELIVER BLOOD VOLUME BACK INTO BABY. MEDICAL TEAM NOTIFIED OF ISSUE, AND VERBAL ORDER FROM ATTENDING TO GIVE FFP IV PUSH BY TRANSPORT TEAM AS THEY DID NOT WANT TO OBTAIN PERIPHERAL IV (PIV) ACCESS DUE TO POOR SKIN INTEGRITY. TRANSPORT TEAM ARRIVED TO BEDSIDE AND DREW UP FFP THAT HAD BEEN FILTERED USING THE BLOOD COMPONENT SET INTO A SYRINGE AND USED MICROBORE EXTENSION SET TO DELIVER FFP PER ORDERS VIA UAC USING IV PUMP INSTEAD OF PUSHING. NO BLOOD FLOWING BACK WITH THIS METHOD AND FFP BEING DELIVERED VIA PUMP OVER 1 HOUR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS LEARNED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT REACHED OUT TO THE CUSTOMER FOR FURTHER ASSISTANCE. IT WAS DETERMINED THAT THE POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED ISSUE OF "BLOOD BACKING UP" WAS DUE TO USE OF TUBING SETS (ZOOMCO TUBING, A NON-BD PRODUCT) THAT DO NOT HAVE ADDITIONAL COMPONENTS SUCH AS CHECK VALVES AND ANTI-SIPHON VALVES, WHICH PREVENTS BLOOD BACKING UP THE LINE (IN ADDITION TO THE ROLLER CLAMP/PINCH CLAMP). CHECK VALVES AND ANTI-SIPHON VALVES ARE BOTH ONE-WAY VALVES THAT ALLOWS FOR FLOW IN ONE DIRECTION ONLY AND PREVENT BLOOD BACKING UP. THE BD CLINICAL PRACTICE CONSULTANT PROVIDED AN EXAMPLE PHOTO OF THE TUBING THAT HAS THESE ADDITIONAL COMPONENTS. IT WAS FURTHER EXPLAINED TO THE CUSTOMER THAT THE LACK OF A CHECK VALVE AND ANTI-SIPHON VALVE ARE POTENTIAL CONTRIBUTING FACTORS TO WHY THE BLOOD BACKED SO FAR UP THE LINE. ANOTHER POTENTIAL CONTRIBUTING FACTOR TO THE ISSUE IS THE UMBILICAL ART LINE, BECAUSE THERE WILL HAVE MORE BACK PRESSURE WITH AN ARTERIAL LINE. ADDITIONALLY, THE PUMP WAS REPORTEDLY SET-UP HIGHER THAN THE PATIENT. THIS COULD ALSO POTENTIALLY CONTRIBUTE TO BLOOD BACKING UP, BECAUSE OF PRESSURE CHANGES. THE PUMP SELECT KEY SHOULD BE POSITIONED LEVEL WITH THE PATIENT'S HEART. PRODUCT RETURN WAS REQUESTED FOR FURTHER INVESTIGATION.
IT WAS REPORTED THAT AN ORDER WAS RECEIVED TO ADMINISTER FRESH FROZEN PLASMA (FFP) VIA UMBILICAL ARTERIAL CATHETER (UAC). PER REPORT, THE HOSPITAL PROTOCOL DICTATES THAT THE BLOOD COMPONENT SET IS 48 INCHES NEONATAL WITH 170 MICRONS FILTER PRIMED AND SET UP WITH SYRINGE WITH EXTRA BLUE CLAMP APPLIED IN ADDITION TO ROLLER CLAMP BEING CLOSED, AS PER UNITS PRACTICE CHANGE. THE SYRINGE USED WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT CALLED "ZOOMCO P.M.P./C.M.P. T-152248 (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." WHEN ATTACHING TO UAC, AND PUMP STARTED 5MLS OVER 1 HOUR PER ORDER. HOWEVER, IT WAS QUICKLY NOTED THAT BLOOD WAS FLOWING BACK OUT OF BABY AND INTO THE TUBING. TRANSFUSION STOPPED AND TUBING CLAMPED, AND UAC FLUSHED TO DELIVER BLOOD VOLUME BACK INTO BABY. MEDICAL TEAM NOTIFIED OF ISSUE, AND VERBAL ORDER FROM ATTENDING TO GIVE FFP IV PUSH BY TRANSPORT TEAM AS THEY DID NOT WANT TO OBTAIN PERIPHERAL IV (PIV) ACCESS DUE TO POOR SKIN INTEGRITY. TRANSPORT TEAM ARRIVED TO BEDSIDE AND DREW UP FFP THAT HAD BEEN FILTERED USING THE BLOOD COMPONENT SET INTO A SYRINGE AND USED MICROBORE EXTENSION SET TO DELIVER FFP PER ORDERS VIA UAC USING IV PUMP INSTEAD OF PUSHING. NO BLOOD FLOWING BACK WITH THIS METHOD AND FFP BEING DELIVERED VIA PUMP OVER 1 HOUR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS LEARNED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT REACHED OUT TO THE CUSTOMER FOR FURTHER ASSISTANCE. IT WAS DETERMINED THAT THE POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED ISSUE OF "BLOOD BACKING UP" WAS DUE TO USE OF TUBING SETS (ZOOMCO TUBING, A NON-BD PRODUCT) THAT DO NOT HAVE ADDITIONAL COMPONENTS SUCH AS CHECK VALVES AND ANTI-SIPHON VALVES, WHICH PREVENTS BLOOD BACKING UP THE LINE (IN ADDITION TO THE ROLLER CLAMP/PINCH CLAMP). CHECK VALVES AND ANTI-SIPHON VALVES ARE BOTH ONE-WAY VALVES THAT ALLOWS FOR FLOW IN ONE DIRECTION ONLY AND PREVENT BLOOD BACKING UP. THE BD CLINICAL PRACTICE CONSULTANT PROVIDED AN EXAMPLE PHOTO OF THE TUBING THAT HAS THESE ADDITIONAL COMPONENTS. IT WAS FURTHER EXPLAINED TO THE CUSTOMER THAT THE LACK OF A CHECK VALVE AND ANTI-SIPHON VALVE ARE POTENTIAL CONTRIBUTING FACTORS TO WHY THE BLOOD BACKED SO FAR UP THE LINE. ANOTHER POTENTIAL CONTRIBUTING FACTOR TO THE ISSUE IS THE UMBILICAL ART LINE, BECAUSE THERE WILL HAVE MORE BACK PRESSURE WITH AN ARTERIAL LINE. ADDITIONALLY, THE PUMP WAS REPORTEDLY SET-UP HIGHER THAN THE PATIENT. THIS COULD ALSO POTENTIALLY CONTRIBUTE TO BLOOD BACKING UP, BECAUSE OF PRESSURE CHANGES. THE PUMP SELECT KEY SHOULD BE POSITIONED LEVEL WITH THE PATIENT'S HEART. PRODUCT RETURN WAS REQUESTED FOR FURTHER INVESTIGATION.
IT WAS REPORTED THAT AN ORDER WAS RECEIVED TO ADMINISTER FRESH FROZEN PLASMA (FFP) VIA UMBILICAL ARTERIAL CATHETER (UAC). PER REPORT, THE HOSPITAL PROTOCOL DICTATES THAT THE BLOOD COMPONENT SET IS 48 INCHES NEONATAL WITH 170 MICRONS FILTER PRIMED AND SET UP WITH SYRINGE WITH EXTRA BLUE CLAMP APPLIED IN ADDITION TO ROLLER CLAMP BEING CLOSED, AS PER UNITS PRACTICE CHANGE. THE SYRINGE USED WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT CALLED "ZOOMCO P.M.P./C.M.P. T-152248 (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." WHEN ATTACHING TO UAC, AND PUMP STARTED 5MLS OVER 1 HOUR PER ORDER. HOWEVER, IT WAS QUICKLY NOTED THAT BLOOD WAS FLOWING BACK OUT OF BABY AND INTO THE TUBING. TRANSFUSION STOPPED AND TUBING CLAMPED, AND UAC FLUSHED TO DELIVER BLOOD VOLUME BACK INTO BABY. MEDICAL TEAM NOTIFIED OF ISSUE, AND VERBAL ORDER FROM ATTENDING TO GIVE FFP IV PUSH BY TRANSPORT TEAM AS THEY DID NOT WANT TO OBTAIN PERIPHERAL IV (PIV) ACCESS DUE TO POOR SKIN INTEGRITY. TRANSPORT TEAM ARRIVED TO BEDSIDE AND DREW UP FFP THAT HAD BEEN FILTERED USING THE BLOOD COMPONENT SET INTO A SYRINGE AND USED MICROBORE EXTENSION SET TO DELIVER FFP PER ORDERS VIA UAC USING IV PUMP INSTEAD OF PUSHING. NO BLOOD FLOWING BACK WITH THIS METHOD AND FFP BEING DELIVERED VIA PUMP OVER 1 HOUR. THERE WAS PATIENT INVOLVEMENT BUT NO HARM. BD HAS LEARNED ADDITIONAL INFORMATION. BD CLINICAL PRACTICE CONSULTANT REACHED OUT TO THE CUSTOMER FOR FURTHER ASSISTANCE. IT WAS DETERMINED THAT THE POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED ISSUE OF "BLOOD BACKING UP" WAS DUE TO USE OF TUBING SETS (ZOOMCO TUBING, A NON-BD PRODUCT) THAT DO NOT HAVE ADDITIONAL COMPONENTS SUCH AS CHECK VALVES AND ANTI-SIPHON VALVES, WHICH PREVENTS BLOOD BACKING UP THE LINE (IN ADDITION TO THE ROLLER CLAMP/PINCH CLAMP). CHECK VALVES AND ANTI-SIPHON VALVES ARE BOTH ONE-WAY VALVES THAT ALLOWS FOR FLOW IN ONE DIRECTION ONLY AND PREVENT BLOOD BACKING UP. THE BD CLINICAL PRACTICE CONSULTANT PROVIDED AN EXAMPLE PHOTO OF THE TUBING THAT HAS THESE ADDITIONAL COMPONENTS. IT WAS FURTHER EXPLAINED TO THE CUSTOMER THAT THE LACK OF A CHECK VALVE AND ANTI-SIPHON VALVE ARE POTENTIAL CONTRIBUTING FACTORS TO WHY THE BLOOD BACKED SO FAR UP THE LINE. ANOTHER POTENTIAL CONTRIBUTING FACTOR TO THE ISSUE IS THE UMBILICAL ART LINE, BECAUSE THERE WILL HAVE MORE BACK PRESSURE WITH AN ARTERIAL LINE. ADDITIONALLY, THE PUMP WAS REPORTEDLY SET-UP HIGHER THAN THE PATIENT. THIS COULD ALSO POTENTIALLY CONTRIBUTE TO BLOOD BACKING UP, BECAUSE OF PRESSURE CHANGES. THE PUMP SELECT KEY SHOULD BE POSITIONED LEVEL WITH THE PATIENT'S HEART. PRODUCT RETURN WAS REQUESTED FOR FURTHER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2276879 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 DA | Male | 8015. |