ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-249508
- Event Type
- Malfunction
- Date Received
- December 13, 2023
- Date of Event
- November 3, 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 : E2401 - INSUFFICIENT INFORMATION, F24 - INSUFFICIENT INFORMATION, B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED ADDITIONAL INFORMATION : DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE RETURN TO MANUF .?, DEVICE EVAL BY MANUFACTURER?, IF OTHER SPECIFY, IMDRF ANNEX E, F, A, B, C, D, G 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. INVESTIGATION SUMMARY: THE REPORT THAT THE BLOOD WAS BACKING UP IN THE IV TUBING FOR PLATELET, DESPITE THE CLAMP BEING CLOSED, WAS REPRODUCED DURING FUNCTIONAL TESTING. ¿ LABORATORY TEST RESULTS PERFORMED ON THE CONCOMITANT SYRINGE MODULE USING THE CONCOMITANT POINT OF CARE UNIT (PCU) WITH RECEIVED NON-COMPATIBLE BLOOD COMPONENT SET AND BECTON DICKINSON (BD) 30ML SYRINGE CONFIRMED THAT THE FLUID FROM THE SYRINGE BACKED UP PAST THE ROLLER CLAMP INTO THE INTRAVENOUS (IV) TUBING WHEN THE ROLLER CLAMP WAS IN THE CLOSED POSITION. ¿ VISUAL INSPECTION OF THE ¿AS-RECEIVED¿ NON-COMPATIBLE BLOOD SET OBSERVED THAT THE BLUE ROLLER COMPONENT OF THE ROLLER CLAMP WAS NOT SEATED PROPERLY INTO THE WHITE CLAMP HOUSING WHEN THE ROLLER CLAMP WAS IN THE CLOSED POSITION. ¿ LABORATORY TESTING WAS CONTINUED BY SEATING THE BLUE ROLLER COMPONENT PROPERLY INTO THE CLAMP HOUSING AND THEN PUTTING THE ROLLER CLAMP IN THE CLOSED POSITION. TEST RESULTS VERIFIED THAT THE INFUSION COMPLETED IN APPROXIMATELY 1 HOUR AS EXPECTED WITH NO OBSERVATION OF THE FLUID BACKING UP PAST THE ROLLER CLAMP INTO THE IV TUBING. ¿ FOLLOW-UP PERFORMED BY BD REPRESENTATIVE SUGGESTED TO THE CUSTOMER THAT THE 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), ARE A CONTRIBUTING FACTOR TO THE REPORTED ISSUE. ¿ FACILITIES HAVE BEEN INFORMED BY THE THIRD-PARTY PARTS NOTICE, DATED FEBRUARY 07, 2022, THAT ONLY ORIGINAL BD PARTS AND COMPONENTS ARE TO BE USED IN ANY MAINTENANCE, REPAIR, OR USE WITH BD DEVICES. ¿ BD HAS NOT TESTED NOR VALIDATED THE PERFORMANCE AND FUNCTIONALITY OF ITS MEDICAL DEVICES WHEN USED WITH REPLACEMENT PARTS MANUFACTURED/REFURBISHED AND SOLD BY THIRD PARTIES AND STRONGLY RECOMMENDS NOT USING ANY THIRD-PARTY COMPONENTS FOR THE MAINTENANCE, SERVICE, AND REPAIR OF BD DEVICES EXCEPT AS EXPLICITLY STATED OTHERWISE. ¿ THE LOGS IDENTIFIED THAT ON (B)(6) 2023 AT 2:07 PM, A GUARDRAILS IV INFUSION WITH DRUG ID: 35 (BLOOD PRODUCT), VOLUME DURATION: 1 HR, CALCULATED RATE OF 11ML/HR AND A VOLUME TO BE INFUSED (VTBI) OF 11ML WAS PROGRAMMED. AT 2:09 PM, THE INFUSION WAS STARTED. PRIMARY VOLUME INFUSED (PVI) WAS RECORDED AS 0.0ML. AT 2:14 PM, THE INFUSION PAUSED. PVI WAS RECORDED AS 1.005ML. AT 2:20 PM, THE DEVICE ALARMED CHECK SYRINGE. AT 2:21 PM, THE DEVICE ALARMED FOR PATIENT PRESSURE AND THE USER CHANNELED OFF THE UNIT. PVI WAS RECORDED AS 1.0313ML. ¿ THE REVIEW OF THE CONCOMITANT SYRINGE MODULE AND CONCOMITANT PCU ERROR LOGS SHOWED NO ERRORS OR MALFUNCTIONS ON THE INCIDENT DATE FOR THE DEVICES. ¿ INTERNAL AND EXTERNAL INSPECTION OF THE CONCOMITANT SYRINGE MODULE, INCLUDING THE SYRINGE MODULE DRIVE TRAIN, DID NOT IDENTIFY ANY IRREGULARITIES. ROOT CAUSE: THE ROOT CAUSE OF THE REPORT THAT THE BLOOD WAS BACKING UP IN THE IV TUBING FOR PLATELET, DESPITE THE CLAMP BEING CLOSED, WAS IDENTIFIED AS THE BLUE ROLLER COMPONENT OF THE ROLLER CLAMP ON THE NON-COMPATIBLE BLOOD SET NOT BEING SEATED PROPERLY INTO THE WHITE CLAMP HOUSING WHEN THE ROLLER CLAMP WAS IN THE CLOSED POSITION. THIS CAUSED THE ROLLER CLAMP TO NOT COMPLETELY PINCH THE TUBING SHUT WHEN THE ROLLER CLAMP WAS CLOSED DURING THE INCIDENT INFUSION. PLEASE REFER TO MFR REPORT # 9616066-2023-02371 FOR THE DISPOSABLE SET ISSUE. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.
CORRECTION: WEIGHT, WEIGHT UNIT, UNIQUE DEVICE IDENTIFIER (UDI)#, PMA / 510(K)#, ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD.
IT WAS REPORTED THAT THE PLATELET TRANSFUSION WAS CONNECTED AND WAS CLAMPED BELOW THE BAG. HOWEVER, IT WAS NOTED THAT THE BLOOD WAS BACKING UP IN THE IV TUBING FOR PLATELET, "DESPITE OF CLAMP BEING CLOSED." THE PLATELET TRANSFUSION WAS REPORTEDLY BEING ADMINISTERED TO A BABY WHO WAS "PALE, GREY IN FACE, MINIMAL MOVEMENT." THE IV TUBING WAS THEN CLAMPED (AT BABY'S SIDE) AND MEDICAL TEAM CALLED TO BEDSIDE. THE ADMISSION NURSE AND TRANSPORT NURSE AT BEDSIDE TO ASSESS THE IV. IT WAS REPORTED THAT THIS OCCURRED DURING USE OF SYRINGE MODULE BUT UNCLEAR IF THE PUMP CONTRIBUTED TO THE BLOOD BACKING UP. THE SYRINGE USED AT THE TIME OF THE EVENT REPORTEDLY WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT "ZOOMCO P.M.P./C.M.P. T-152248 (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." IT WAS REPORTED THAT DUE TO THE ISSUE, THERE WAS AN "ESTIMATED BLOOD LOSS" OF 3ML. THE BABY'S CONDITION REPORTEDLY "REMAINED THE SAME, ULTIMATELY DECEASED." PER CLINICIAN, "BABY WHO DIED HAD DIED OF OTHER CAUSES. NO REASON TO SUSPECT THAT BLOOD BACKING UP CONTRIBUTED IN ANY WAY." 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 THE PLATELET TRANSFUSION WAS CONNECTED AND WAS CLAMPED BELOW THE BAG. HOWEVER, IT WAS NOTED THAT THE BLOOD WAS BACKING UP IN THE IV TUBING FOR PLATELET, "DESPITE OF CLAMP BEING CLOSED." THE PLATELET TRANSFUSION WAS REPORTEDLY BEING ADMINISTERED TO A BABY WHO WAS "PALE, GREY IN FACE, MINIMAL MOVEMENT." THE IV TUBING WAS THEN CLAMPED (AT BABY'S SIDE) AND MEDICAL TEAM CALLED TO BEDSIDE. THE ADMISSION NURSE AND TRANSPORT NURSE AT BEDSIDE TO ASSESS THE IV. IT WAS REPORTED THAT THIS OCCURRED DURING USE OF SYRINGE MODULE BUT UNCLEAR IF THE PUMP CONTRIBUTED TO THE BLOOD BACKING UP. THE SYRINGE USED AT THE TIME OF THE EVENT REPORTEDLY WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT "ZOOMCO P.M.P./C.M.P. (B)(4) (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." IT WAS REPORTED THAT DUE TO THE ISSUE, THERE WAS AN "ESTIMATED BLOOD LOSS" OF 3ML. THE BABY'S CONDITION REPORTEDLY "REMAINED THE SAME, ULTIMATELY DECEASED." PER CLINICIAN, "BABY WHO DIED HAD DIED OF OTHER CAUSES. NO REASON TO SUSPECT THAT BLOOD BACKING UP CONTRIBUTED IN ANY WAY." 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 THE PLATELET TRANSFUSION WAS CONNECTED AND WAS CLAMPED BELOW THE BAG. HOWEVER, IT WAS NOTED THAT THE BLOOD WAS BACKING UP IN THE IV TUBING FOR PLATELET, "DESPITE OF CLAMP BEING CLOSED." THE PLATELET TRANSFUSION WAS REPORTEDLY BEING ADMINISTERED TO A BABY WHO WAS "PALE, GREY IN FACE, MINIMAL MOVEMENT." THE IV TUBING WAS THEN CLAMPED (AT BABY'S SIDE) AND MEDICAL TEAM CALLED TO BEDSIDE. THE ADMISSION NURSE AND TRANSPORT NURSE AT BEDSIDE TO ASSESS THE IV. IT WAS REPORTED THAT THIS OCCURRED DURING USE OF SYRINGE MODULE BUT UNCLEAR IF THE PUMP CONTRIBUTED TO THE BLOOD BACKING UP. THE SYRINGE USED AT THE TIME OF THE EVENT REPORTEDLY WAS "BD 30ML" AND THE TUBING WAS A NON-BD PRODUCT "ZOOMCO P.M.P./C.M.P. T-152248 (BLOOD COMPONENT SET 48¿ NEO-NATAL, WITH 170 MICRONS FILTER, PRIMING VOLUME 6.0ML APPROX.)." IT WAS REPORTED THAT DUE TO THE ISSUE, THERE WAS AN "ESTIMATED BLOOD LOSS" OF 3ML. THE BABY'S CONDITION REPORTEDLY "REMAINED THE SAME, ULTIMATELY DECEASED." PER CLINICIAN, "BABY WHO DIED HAD DIED OF OTHER CAUSES. NO REASON TO SUSPECT THAT BLOOD BACKING UP CONTRIBUTED IN ANY WAY." 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 |
|---|---|---|---|---|---|---|---|
| 1778329 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 DA | Female | 8015. |