ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-29573
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- April 24, 2024
- Report Date
- October 8, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403424267
- PMA / PMN Number
- K133532
- Removal / Correction Number
- Z-2719-2020
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 505
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.
OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE, D15 - CAUSE NOT ESTABLISHED CORRECTION: UNIQUE DEVICE IDENTIFIER (UDI)# ADDED PI TO THE UNIQUE DEVICE IDENTIFIER (UDI)# FIELD. ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?, RETURNED TO MANUFACTURER ON, DEVICE EVAL BY MANUFACTURER? , IMDRF ANNEX A,G,B,C AND D CODES ,REMEDIAL ACTION REQUIRED, REMEDIAL ACTION #.
ADDITIONAL INFORMATION : IMDRF ANNEX B CODE 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.
ADDITIONAL INFORMATION : IMDRF ANNEX B CODE AND MANUFACTURER NARRATIVE. A DEVICE HISTORY RECORD, COMPLAINT HISTORY REVIEW, AND RISK REVIEW ON FAILURE MODES ARE PERFORMED ON EACH DEVICE WITH REPORTABLE MALFUNCTION(S) ALONG WITH OTHER METHODS OF INVESTIGATION AS CODED IN SECTION H6 OF THIS MDR REPORT. INVESTIGATION SUMMARY: THE COMPLAINT OF A SYRINGE MODULE VOLUME DISCREPANCY WAS IDENTIFIED AS DUE TO USER PROGRAMMING. ALTHOUGH LOG REVIEW SHOWED ¿TERUMO 10ML¿ SYRINGE WAS SELECTED FOR USE, THE RETURNED PICTURE SHOWED A BD 10ML SYRINGE WAS ACTUALLY INSTALLED. ¿ THE PRINTED PICTURE THAT WAS RETURNED WITH THE DEVICE FOR INVESTIGATION SHOWED A BD 10ML SYRINGE WITH THE PLUNGER SET TO APPROXIMATELY 1ML WAS LOADED INTO THE SYRINGE MODULE, BUT THE PCU DISPLAYED OML AS THE AVAILABLE VOLUME. ¿ REVIEW OF THE SYRINGE MODULE EVENT LOG SHOWED, ON (B)(6) 2024 AT 1:04 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED A SYRINGE TYPE OF TERUMO 10ML (AVAILABLE VOLUME = 10.5753 ML) OF AN UNKNOWN MEDICATION TO INFUSE AT A RATE OF 10 ML/HR (VTBI= 0.65 ML). ¿ AT T08 PM, THE INFUSION COMPLETED. ¿ AT 1:09 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED AN INFUSION AT A RATE OF 99 ML/HR (VTBI= 9.86 ML) ¿ AT 1.15 PM, THE INFUSION COMPLETED ¿ AT 1 16 PM, THE SYRINGE MODULE WAS SELECTED AND PROGRAMMED VTBI OF 0.0053 ML TO INFUSE AT A RATE OF 99 ML/HR ¿ LESS THAN THIRTY (30) SECONDS LATER, THE INFUSION COMPLETED. ¿ REVIEW OF THE LOGS COULD NOT DETERMINE THE VOLUME IN THE SYRINGE AT THE END OF INFUSION ¿ REVIEW OF THE SYRINGE MODULE ERROR LOG SHOWED NO ERRORS WERE RECORDED ON THE REPORTED EVENT DATE. ¿ THE EVENT PCU AND ITS ASSOCIATED LOGS WERE NOT RETURNED FOR INVESTIGATION; THEREFORE, SOME PROGRAMMING PARAMETERS AND DRUG INFORMATION COULD NOT BE CONFIRMED ¿ LABORATORY TESTING OF THE RETURNED SYRINGE MODULE SHOWED THE DEVICE WAS ACCURATELY DETECTING SYRINGE TYPE AND AVAILABLE VOLUME WITHIN SPECIFICATION ¿ EXTERNAL AND INTERNAL INSPECTION OF THE DEVICE SHOWED INCIDENTAL FINDINGS ONLY WITH NO RELATION TO REPORTED COMPLAINT. ¿ INSPECTION AND TESTING OF THE EVENT SYRINGE AND ADMINISTRATION SET COULD NOT BE PERFORMED BECAUSE THEY WERE NOT RETURNED FOR INVESTIGATION ¿ SELECTING AN INCORRECT SYRINGE MAY CAUSE AN UNDER INFUSION OR OVER INFUSION TO THE PATIENT ¿ THE SYSTEM WAS BEING USED FOR TREATMENT PURPOSES AS INTENDED PER 21 CFR 820.198(D)(2) ROOT CAUSE: THE ROOT CAUSE OF THE COMPLAINT OF SYRINGE MODULE VOLUME DISCREPANCY WAS IDENTIFIED AS USER PROGRAMMING. ALTHOUGH THE PROVIDED PICTURE SHOWED THE SYRINGE MODULE WAS LOADED WITH A BD 10ML SYRINGE, LOG REVIEW SHOWED THE USER SELECTED TERUMO 10ML DURING INFUSION PROGRAMMING. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A1801, G02017, C0601, D01 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 PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
IT WAS REPORTED THAT THE SYRINGE PUMP MODULE WAS PROGRAMMED TO INFUSE NORMAL SALINE FOR 99ML/HR AND IT SHOWED 9.86ML AVAILABLE IN THE FLUSH SYRINGE. AFTER A FEW MINUTES, THE PUMP BEEPED COMPLETED BUT THERE WAS 1ML LEFT IN THE NORMAL SALINE FLUSH TO BE INFUSED. WHEN TRYING TO ADD VOLUME, THE PUMP READ THE VOLUME TO BE INFUSED AS 0ML AND WOULD NOT ALLOW THE CUSTOMER TO CHANGE THE VALUE, AS IT SAID 1ML "EXCEEDS REMAINING AMOUNT OF 0ML." THE PUMP WAS SET BACK TO THE ACCURATE READING AND THE REMAINING DRUG INFUSED THROUGH THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1651828 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8110 | 10885403424267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | 8015. |