ALARIS PUMP MODULE
Report
- Report Number
- 2016493-2021-26160
- Event Type
- Malfunction
- Date Received
- February 26, 2021
- Date of Event
- August 30, 2018
- Report Date
- February 9, 2021
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
SAMPLE INSPECTION: AN EXTERNAL AND INTERNAL INSPECTION OF THE CUSTOMER¿S INCIDENT PUMP IDENTIFIED THE MALE AND FEMALE IUI WITH SIGNS OF UNIDENTIFIED FILM CONTAMINANTS ON THE CONNECTOR CONTACT PINS. THE MALE CONNECTED WAS OBSERVED WITH DRIED FLUID RESIDUE. AN IMPACT DENT WAS NOTED ON THE TOP REAR RIGHT CORNER OF THE REAR CASE. THE DOOR LATCH ASSEMBLY, INCLUDING THE SPRING AND THE SEAR WERE NON BD MANUFACTURED PARTS. ALL OTHER INSPECTED COMPONENTS WERE OBSERVED AS BD MANUFACTURED PARTS. THE BEZEL DATE CODE WAS NOTED NOV 2017. NO OTHER OBVIOUS ISSUES OR ANOMALIES WERE IDENTIFIED WITH THE DEVICE DURING THE INSPECTION. LOG ANALYSIS RESULTS: RETRIEVED SYSTEM LOGS SHOWED THE EVENT LOGS ASSOCIATED TO THE DATE OF THE EVENT AUG 30 2018 HAD BEEN OVER-WRITTEN, THEREFORE AN ANALYSIS OF THE LOGS COULD NOT BE PERFORMED. A REVIEW OF THE SYSTEM ERROR LOGS SHOWED NO RECORDS ASSOCIATED TO THE REPORTED EVENT. TEST RESULTS: A TIMED RATE ACCURACY TEST IDENTIFIED THE PUMP FAILING FOR RATE ACCURACY, SHOWING THE PUMP UNDER INFUSING. HOWEVER, THIS APPEARED TO BE AN INCIDENTAL ISSUE AND WAS ASSOCIATED TO THE PUMP MODULE BEING OUT OF RATE CALIBRATION, WITH A VPMR INITIALLY OBSERVED AT 167.1 L. TEST METHODS: TESTING WAS PERFORMED PER THE TIMED RATE ACCURACY TEST METHOD 1503-001-006, DIR# 10000360036 AND ALARIS SYSTEM OVER INFUSION TEST METHOD 1503-001-029, DIR# 10000360063 . (1503-001-006-R (01) TIMED RATE ACCURACY TEST METHOD.PDF) & 1503-001-002-R (01) ALARIS SYSTEM OVER INFUSION TEST METHOD. DEVICE HISTORY REVIEW : A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 02/23/2015. THE REVIEW WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR S/N (B )(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN TRACKWISE AND SAP WAS PERFORMED FOR THE S/N (B)(6) WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE FOR THIS CUSTOMER. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WITH AN OVER INFUSION WAS NOT DETERMINED AS A RESULT OF THIS INVESTIGATION. THE CUSTOMER¿S REPORTED COMPLAINT OF AN OVER INFUSION WAS NOT CONFIRMED DURING A REVIEW OF THE LOGS OR REPLICATED DURING TESTING. BASED ON LOG ANALYSIS RESULTS THE LOGS WERE OVER-WRITTEN DURING THE REPORTED TIME OF THE EVENT, CONSEQUENTLY DETAILS ASSOCIATED TO THE ALLEGED INCIDENT WERE NOT AVAILABLE. THE DOOR LATCH ASSEMBLY, INCLUDING THE SEAR WERE IDENTIFIED AS NON BD PARTS. TIMED RATE ACCURACY TESTING WITH THE AS RECEIVED NON BD PARTS SHOWED THE PUMP MODULE OUT OF RATE CALIBRATION, UNDER INFUSING. HOWEVER, THIS WAS NOT FOUND TO BE ASSOCIATED TO THE REPORTED OVER INFUSION EVENT. THE PUMP MODULE INFUSION WAS BEING USED FOR TREATMENT. THE MECHANISM ASSEMBLY WAS DISASSEMBLED DURING THE INTERNAL INSPECTION OF THE INVESTIGATION AND WILL BE REPLACED BY SERVICE. MECHANISM ASSEMBLIES CANNOT BE REASSEMBLED SINCE MANUFACTURING PERFORMS SEVERAL TESTS NOT AVAILABLE TO CAD, SERVICE DEPOT OR THE CUSTOMER. MANUFACTURING TESTS INVOLVE AN OCCLUDER SPRING TEST, AN X-RAY SPRING INSPECTION AND INSTALL OF NEW ONE TIME USE TORQUE SCREWS WITH APPLIED TAMPER SEAL MATERIAL.
THOUGH REQUESTED, THE PATIENT DEMOGRAPHICS WERE NOT PROVIDED. REMOVE 'OTHER - BIOMED' FROM G.3. REPLACED WITH HEALTH PROFESSIONAL THE CUSTOMER¿S REPORTED COMPLAINT OF AN OVER INFUSION WAS NOT CONFIRMED DURING A REVIEW OF THE LOGS OR REPLICATED DURING TESTING. INSPECTION: THE SOURCE PUMP MODULE WAS RECEIVED WITH THE INSTRUMENT SEAL BROKEN. THE SEAR, SPRING AND HINGES ARE INTACT AND FUNCTIONAL. PLATEN, POSTS/HINGE, PINS/SPRINGS BUTTONS ARE ALL INTACT AND NOT INTERFERING WITH DOOR OPERATION. THE DOOR LATCH AND THE PIVOT LATCH SCREW ARE IN GOOD CONDITION. THE MALE AND FEMALE IUI SHOWED SIGNS OF UNIDENTIFIED FILM CONTAMINANTS ON THE CONNECTOR CONTACT PINS. EVIDENCE OF DRIED FLUID RESIDUE WAS ALSO NOTED MALE IUI CONNECTOR. AN IMPACT DENT WAS NOTED ON THE TOP REAR RIGHT CORNER OF THE REAR CASE. THE DOOR LATCH ASSEMBLY, INCLUDING THE SPRING AND THE SEAR WERE NON BD MANUFACTURED PARTS. ALL OTHER INSPECTED COMPONENTS WERE OBSERVED AS BD MANUFACTURED PARTS. THERE WERE NO OTHER OBVIOUS ISSUES OR ANOMALIES OBSERVED DURING THE INSPECTION OF THE SOURCE DEVICE. RETRIEVED SYSTEM LOGS SHOWED THE EVENT LOGS ASSOCIATED TO THE DATE OF THE EVENT (B)(6) 2018 HAD BEEN OVER-WRITTEN, THEREFORE AN DETAILS ASSOCIATED WITH THE ALLEGED INCIDENT AND ANALYSIS OF THE LOGS COULD NOT BE PERFORMED. THE DOOR LATCH ASSEMBLY, INCLUDING THE SEAR WERE IDENTIFIED AS NON BD PARTS. TIMED RATE ACCURACY TESTING WITH THE AS RECEIVED NON BD PARTS SHOWED THE PUMP MODULE OUT OF RATE CALIBRATION, UNDER INFUSING. HOWEVER, THIS WAS NOT FOUND TO BE ASSOCIATED TO THE REPORTED OVER INFUSION EVENT. A REVIEW OF THE SYSTEM ERROR LOGS SHOWED NO RECORDS ASSOCIATED TO THE REPORTED EVENT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WITH AN OVER INFUSION WAS NOT DETERMINED AS A RESULT OF THIS INVESTIGATION. THE INCIDENT ADMINISTRATION SET WAS NOT RETURNED FOR AN INSPECTION TO DETERMINE IF THE SET CONTRIBUTED TO THE REPORTED EVENT. DEVICE HISTORY REVIEW : A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 02/23/2015. THE REVIEW WAS PERFORMED BEGINNING FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR S/N (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE.
IT WAS INITIALLY REPORTED THAT AN OVERINFUSION OCCURRED AND THE CUSTOMER WANTED TO DOWNLOAD THE ERROR AND EVENT LOGS. AT A LATER TIME, THE CUSTOMER THEN STATED THERE WAS "NO OVERINFUSION OR PUMP MALFUNCTION THAT HE WAS CURRENTLY AWARE OF AND WAS JUST REQUESTING THE KEY STROKE REPORT FROM THE PCU MODULE" DUE TO ACTIVE LAW SUIT. NO PATIENT HARM WAS REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.
IT WAS INITIALLY REPORTED THAT AN OVERINFUSION OCCURRED AND THE CUSTOMER WANTED TO DOWNLOAD THE ERROR AND EVENT LOGS. AT A LATER TIME, THE CUSTOMER THEN STATED THERE WAS "NO OVERINFUSION OR PUMP MALFUNCTION THAT HE WAS CURRENTLY AWARE OF AND WAS JUST REQUESTING THE KEY STROKE REPORT FROM THE PCU MODULE" DUE TO ACTIVE LAW SUIT. NO PATIENT HARM WAS REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.
NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.
IT WAS INITIALLY REPORTED THAT AN OVERINFUSION OCCURRED AND THE CUSTOMER WANTED TO DOWNLOAD THE ERROR AND EVENT LOGS. AT A LATER TIME, THE CUSTOMER THEN STATED THERE WAS "NO OVERINFUSION OR PUMP MALFUNCTION THAT WE HE WAS CURRENTLY AWARE OF AND WAS JUST REQUESTING THE KEY STROKE REPORT FROM THE PCU MODULE" DUE TO ACTIVE LAW SUIT. NO PATIENT HARM WAS REPORTED AND NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 280258 | ALARIS PUMP MODULE | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8015| 8100| PRI TUBING| PRI TUBING X2, 8100, 8015, TD UNK| PRI TUBING X2, 8100, 8015, TD UNK |