ALARIS SYSTEM
Report
- Report Number
- 2016493-2023-249554
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- November 10, 2023
- Report Date
- September 26, 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, 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 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. H3 OTHER TEXT : NOT APPLICABLE. DEVICE EVALUATED BY BD.
CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)#, PMA / 510(K)# ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: MANUFACTURER NARRATIVE. INVESTIGATION SUMMARY: THE REPORT ISSUE OF THE PATIENT¿S BLOOD BEING PULLED BACK INTO THE TUBING FROM THE PATIENT ALL THE WAY UP INTO THE PLATELET BAG WAS NOT CONFIRMED THROUGH REVIEW OF THE DEVICE LOGS OR THROUGH TESTING. ¿ LABORATORY TEST RESULTS PERFORMED ON THE SUSPECT SYRINGE MODULE AND NON-BD BLOOD COMPONENT SET AND BECTON DICKINSON (BD) 50ML SYRINGE SHOWED THE SYSTEM TO BE OPERATING AS EXPECTED. ¿ THE NON-BD (ZOOMCO P.M.P./C.M.P. T-152248; BLOOD COMPONENT SET 48¿ NEO-NATAL) DURING THE REPORTED INCIDENT PASSED LABORATORY TESTING; HOWEVER, TESTING SHOWED THAT THE ROLLER WITHIN THE CLAMP CAN EASILY BE DISLODGED AND WILL NOT FULLY CLAMP THE LINE AS INTENDED AND ALLOWS BACKFLOW FROM BOTH THE PATIENT AND THE FLUID IN THE DISPOSABLE SYRINGE TO FLOW INTO THE IV BAG. ¿ THE LOG REVIEW IDENTIFIED THE INFUSION STARTED AT 11:52:53 AM ON (B)(6) 2023 WHERE DRUG ID 35 (BLOOD PRODUCT) HAD BEEN PROGRAMMED TO INFUSE. ¿ THE INFUSION WAS PAUSED 12:23:37 PM AND THEN THE SYRINGE WAS MANIPULATED AND ALARMED FOR CHECK SYRINGE AT 12:26:19 PM WHERE THE CLAMP WAS OPENED AND AGAIN AT 12:26:39 PM THE SYRINGE MODULE ALARMED FOR CHECK SYRINGE. ¿ THE SYRINGE MODULE WAS SELECTED, AND THE DISPOSABLE SYRINGE PARAMETERS WERE RESELECTED AND CONFIRMED AT 12:30:05 PM. THE INFUSION WAS RESTARTED AT 12:30:41 PM AND CONTINUED TILL 12:58:58 PM WHERE IT WENT INTO KVO. ¿ THE SYRINGE WAS CHANNELED OFF AT 1:00:29 PM WITH A PVI 31.3524 ML. ¿ ACCORDING TO THE BD ALARIS SYSTEM WITH GUARDRAILS SUITE MX: ¿ PROPER OPERATION OF BD ALARIS SYSTEM REQUIRES THAT YOU ARE FAMILIAR WITH RELATED FEATURES, SETUP, PROGRAMMING IV SETS, AND ACCESSORIES. READ ALL INSTRUCTIONS, INCLUDING THOSE FOR ALL ATTACHED MODULE(S) AND ASSOCIATED DISPOSABLES BEFORE USING THE BD ALARIS SYSTEM. ¿ USE ONLY BD APPROVED PARTS WHEN PERFORMING CORRECTIVE MAINTENANCE OR REPAIRS. USE OF THIRD-PARTY PARTS CAN AFFECT THE SAFETY AND EFFICACY OF BD ALARIS AND ALARIS DEVICES LEADING TO RISK OF DEVICE FAILURE, PATIENT INJURY, OR EVEN DEATH. ¿ THE DEVICE WAS IN USE FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2). ROOT CAUSE: THE PROBABLE CAUSE OF THE REPORTED PATIENT¿S BLOOD BEING PULLED BACK INTO THE TUBING FROM THE PATIENT ALL THE WAY UP INTO THE PLATELET BAG DETERMINED TO BE DUE TO THE THIRD PARTY SET CLAMP ROLLER BECOMING DISLODGED AND ALLOWING BACKFLOW. ADDITIONAL POTENTIAL CONTRIBUTING FACTORS TO THE REPORTED ISSUE OF "BLOOD BACKING UP" CAN BE DUE TO USE OF 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). ANOTHER POTENTIAL CONTRIBUTING FACTOR IS THE USE OF AN UMBILICAL ARTERIAL LINE BECAUSE THERE WILL BE 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 DIFFERENCES. THE SYRINGE MODULE SELECT KEY SHOULD BE POSITIONED LEVEL WITH THE PATIENT'S HEART. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A040507, G04061 AND C07 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 THE SYRINGE MODULE WAS SET UP TO TRANSFUSE PLATELETS VIA PERIPHERAL IV. PLATELETS WERE HOUSED IN BD 50ML SYRINGE WITH PLATELET BAG STILL ATTACHED TO TUBING AND CLAMPED. THE TUBING USED WAS BLOOD COMPONENT SET 48 INCHES NEONATAL WITH 170 MICRONS FILTER. PER REPORT, "APPROPRIATE CLAMPS WERE IN PLACE (CLAMP TO THE BAG WAS CLAMP)." FORTY-FIVE (45) MINUTES INTO PLATELET TRANSFUSION, THE PATIENT'S BLOOD WAS REPORTEDLY "BEING PULLED INTO THE TUBING FROM THE PATIENT ALL THE WAY UP INTO THE PLATELET BAG." PER REPORT, THE SYRINGE USED WAS "BD 50ML" 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.)." THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT 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 THE SYRINGE MODULE WAS SET UP TO TRANSFUSE PLATELETS VIA PERIPHERAL IV. PLATELETS WERE HOUSED IN BD 50ML SYRINGE WITH PLATELET BAG STILL ATTACHED TO TUBING AND CLAMPED. THE TUBING USED WAS BLOOD COMPONENT SET 48 INCHES NEONATAL WITH 170 MICRONS FILTER. PER REPORT, "APPROPRIATE CLAMPS WERE IN PLACE (CLAMP TO THE BAG WAS CLAMP)." FORTY-FIVE (45) MINUTES INTO PLATELET TRANSFUSION, THE PATIENT'S BLOOD WAS REPORTEDLY "BEING PULLED INTO THE TUBING FROM THE PATIENT ALL THE WAY UP INTO THE PLATELET BAG." PER REPORT, THE SYRINGE USED WAS "BD 50ML" 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.)." THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT 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 THE SYRINGE MODULE WAS SET UP TO TRANSFUSE PLATELETS VIA PERIPHERAL IV. PLATELETS WERE HOUSED IN BD 50ML SYRINGE WITH PLATELET BAG STILL ATTACHED TO TUBING AND CLAMPED. THE TUBING USED WAS BLOOD COMPONENT SET 48 INCHES NEONATAL WITH 170 MICRONS FILTER. PER REPORT, "APPROPRIATE CLAMPS WERE IN PLACE (CLAMP TO THE BAG WAS CLAMP)." FORTY-FIVE (45) MINUTES INTO PLATELET TRANSFUSION, THE PATIENT'S BLOOD WAS REPORTEDLY "BEING PULLED INTO THE TUBING FROM THE PATIENT ALL THE WAY UP INTO THE PLATELET BAG." PER REPORT, THE SYRINGE USED WAS "BD 50ML" 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.)." THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT 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 |
|---|---|---|---|---|---|---|---|
| 1770217 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403811043 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Male | 8015. |