ALARIS SYSTEM
Report
- Report Number
- 2016493-2024-28904
- Event Type
- Injury
- Date Received
- June 11, 2024
- Date of Event
- April 2, 2024
- Report Date
- October 9, 2024
- Manufacturer
- CAREFUSION SD
- Product Code
- FRN
- UDI-DI
- 10885403810015
- PMA / PMN Number
- K133532
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 505
Narratives
OMIT: B17 - DEVICE NOT RETURNED, C20 - NO FINDINGS AVAILABLE. 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, 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 REPORTED ISSUE THAT THERE WAS AN UNDER INFUSION OF HEPARIN WAS CONFIRMED VIA LOG ANALYSIS TO BE CAUSED BY USER PROGRAMMING. ¿ THE ALARIS SYSTEM USER MANUAL (V9.33), STATES BEFORE SELECTING THE START KEY TO BEGIN AN INFUSION TO ¿VERIFY THE CORRECT PARAMETERS¿. ¿ AN INFUSION OF HEPARIN AT 25000UNIT/250ML (BCM_ALIAS_NDC: 15846) WAS STARTED ON THE SUSPECT PUMP MODULE S/N: (B)(6) ON THE DATE (B)(6)2024 AT THE TIME OF 3:01 AM. THE DOSE WAS AT 24 UNIT/KG/H, AND THE SYSTEM CALCULATED THE INFUSION RATE TO BE 13.44ML/H. THE VOLUME TO BE INFUSED (VTBI) WAS AT 250ML. ¿ THE PRIMARY VOLUME INFUSED (PVI) FOR THE INFUSION OF HEPARIN WHEN IT WAS STARTED ABOVE WAS RECORDED AT 12,066.3ML. THIS VALUE WAS AN ACCUMULATED TOTAL FROM PRIOR PERFORMED INFUSIONS. ¿ AT THE TIME OF 8:44 AM THE DOSE WAS MANUALLY DECREASED TO 11 UNIT/KG/H (RATE=6.16ML/H). THE PVI WAS RECORDED AT 12,142.5ML. THE HEPARIN INFUSION DELIVERED 76.2ML AT THE DOSE OF 24 UNIT/KG/H. THIS VALUE WAS DERIVED BY SUBTRACTING THE PVI (12,066.3ML) AT THE START OF THE INFUSION FROM THE PVI (12,142.5ML) AT THE DOSE CHANGE. ¿ AT THE TIME OF 9:43 AM THE DOSE WAS FIRST INCREASED TO 24 UNIT/KG/H THEN WAS CANCELED AND CHANGED TO 23 UNIT/KG/H (RATE=12.88ML/H). THE PVI WAS RECORDED AT 12,148.4ML WHEN THE DOSE WAS INCREASED. THE HEPARIN INFUSION DELIVERED 5.9ML WHILE AT THE DOSE OF 11 UNIT/KG/H. THIS VALUE WAS DERIVED BY SUBTRACTING THE PVI (12,142.5ML) AT THE START OF THE INFUSION DOSE OF 11 UNIT/KG/H FROM THE PVI (12,148.4ML) AT THE DOSE CHANGE TO 23 UNIT/KG/H. ¿ AT THE TIME OF 9:44 AM A REMOTE IV ORDER OF HEPARIN AT 25000UNIT/250ML (BCM_ALIAS_NDC: 15846) WAS RECEIVED WITH THE DOSE AT 23 UNIT/KG/H (RATE=12.88ML/H) AND THE VTBI AT 250ML. THE INFUSION ORDER WAS ACCEPTED AND STARTED BY THE CLINICIAN. ¿ AT THE TIME OF 10:36AM THE HEPARIN INFUSION WAS MANUALLY TURNED OFF. THE PVI WAS RECORDED AT 12,159.8ML. THE HEPARIN INFUSION DELIVERED 11.4ML WHILE AT THE DOSE OF 23 UNIT/KG/H. THIS VALUE WAS DERIVED BY SUBTRACTING THE PVI (12,148.4ML) AT THE START OF THE INFUSION DOSE OF 23 UNIT/KG/H FROM THE PVI (12,159.8ML) AT THE TERMINATION OF THE INFUSION. ¿ THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION DURING RATE ACCURACY TESTING BY BD. ¿ THE INSPECTION PROCESS IDENTIFIED PHYSICAL DAMAGE ON THE PUMP MODULE WITH THE MEMBRANE FRAME BROKEN IN THE VICINITY OF THE PLASTIC SNAP RIVET AND AT THE PIVOT LATCH SCREW TORSION SPRING SEAT ON THE DOOR. THE REAR CASE AND BEZEL HAD FLUID INGRESS DAMAGE. THE MOTOR CONTROLLER BOARD WAS MISSING THE COMPONENT C36 (BROKEN OFF). THE IUI BRACKET MOUNTING TAB ON THE PUMPING MECHANISM FRAME WAS FOUND BROKEN OFF. HOWEVER, THE DAMAGE DID NOT AFFECT THE DEVICE¿S PERFORMANCE DURING TESTING OR WAS FOUND TO BE A CONTRIBUTING FACTOR FOR THE REPORTED ISSUE. ROOT CAUSE: BASED ON THE EXTENSIVE LOG ANALYSIS, THE ROOT CAUSE OF THE REPORTED ISSUE THAT THERE WAS AN UNDER INFUSION OF HEPARIN IS ATTRIBUTED TO USER PROGRAMMING. THE DEVICE LOG IDENTIFIED THAT THE INFUSION DOSE WAS MANUALLY DECREASED FROM 24 UNIT/KG/H TO 11 UNIT/KG/H AND THEN WAS INCREASED TO 23 UNIT/KG/H. THE SUSPECT PUMP MODULE WAS FOUND TO BE INFUSING WITHIN SPECIFICATION. NOTE THAT THIS REPORT LISTS IMDRF ANNEX A0401, A0404, A1801, G02017, G04067, G04037, G0405206, G04088, C07, C0601, C16 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.
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.
IT WAS REPORTED THAT DURING HANDOFF, HEPARIN (25,000 UNITS/250ML) WAS SCANNED TO PROGRAM THE INFUSION. PER REPORT, THE INFUSION SETTING WAS 13.44ML/HR. ("CORRECT RATE"); HOWEVER, THE PUMP RATE REPORTEDLY "SWITCHED BACK TO ORIGINAL ORDER OF "(B)(4) UNITS". FROM 7:17 TO 8:14, THE DEVICE REPORTEDLY INDICATED THAT IT INFUSED AT 13.44ML/HR., (B)(4) UNITS. THE CUSTOMER STATED THAT "IT SHOULD HAVE BEEN 13.44ML/HR. AND 24 UNITS, "UNIT AND RATE SHOULD CHANGE SIMULTANEOUSLY". THE NURSE REPORTEDLY "NOTICED IT LATER AROUND ONE HOUR WHILE CHECKING ANTIXA (LEVEL) RESULTS AND CORRECTED". FOR AROUND ONE HOUR, THE PATIENT REPORTEDLY RECEIVED HALF DOSE OF THE HEPARIN THEY SHOULD HAVE RECEIVED. DUE TO THE EVENT, THE PROVIDER "HELD HEPARIN AS PATIENT'S HGB (HEMOGLOBIN LEVEL) DROPPED AND THE CT (SCAN) SHOWED THEY WERE HAVING BLEED". HOWEVER, THE CUSTOMER (ASSISTANT NURSE MANAGER) HAS INDICATED THAT "THE BLEED WAS NOT CAUSED BY THE EQUIPMENT ERROR BECAUSE THE ML/HR. WAS THE SAME." PER REPORT, THE PATIENT'S BLOOD PRESSURE WAS 97/62, HEMOGLOBIN 5.7, AND THE CT SCAN ANGIOGRAPHY OF THE ABDOMEN AND PELVIS RESULT WAS: "THERE IS AN ACUTE LEFT ILIOPSOAS HEMATOMA, WITHOUT EVIDENCE FOR ACTIVE HEMORRHAGE." HEPARIN DRIP WAS THEN STOPPED, 2 UNITS OF PACKED RED BLOOD CELL (PRBC) WERE TRANSFUSED, AND COMPLETE BLOOD COUNT (CBC) LEVELS WERE MONITORED. THERE WERE NO OTHER INTERVENTIONS PER CUSTOMER'S REPORT. THE "HGB RESPONDED APPROPRIATELY TO TRANSFUSIONS. BPS (BLOOD PRESSURE) STABLE."
IT WAS REPORTED THAT DURING HANDOFF, HEPARIN (25,000 UNITS/250ML) WAS SCANNED TO PROGRAM THE INFUSION. PER REPORT, THE INFUSION SETTING WAS 13.44ML/HR. ("CORRECT RATE"); HOWEVER, THE PUMP RATE REPORTEDLY "SWITCHED BACK TO ORIGINAL ORDER OF "12 UNITS". FROM 7:17 TO 8:14, THE DEVICE REPORTEDLY INDICATED THAT IT INFUSED AT 13.44ML/HR.,12 UNITS. THE CUSTOMER STATED THAT "IT SHOULD HAVE BEEN 13.44ML/HR. AND 24 UNITS, "UNIT AND RATE SHOULD CHANGE SIMULTANEOUSLY". THE NURSE REPORTEDLY "NOTICED IT LATER AROUND ONE HOUR WHILE CHECKING ANTIXA (LEVEL) RESULTS AND CORRECTED". FOR AROUND ONE HOUR, THE PATIENT REPORTEDLY RECEIVED HALF DOSE OF THE HEPARIN THEY SHOULD HAVE RECEIVED. DUE TO THE EVENT, THE PROVIDER "HELD HEPARIN AS PATIENT'S HGB (HEMOGLOBIN LEVEL) DROPPED AND THE CT (SCAN) SHOWED THEY WERE HAVING BLEED". HOWEVER, THE CUSTOMER (ASSISTANT NURSE MANAGER) HAS INDICATED THAT "THE BLEED WAS NOT CAUSED BY THE EQUIPMENT ERROR BECAUSE THE ML/HR. WAS THE SAME." PER REPORT, THE PATIENT'S BLOOD PRESSURE WAS 97/62, HEMOGLOBIN 5.7, AND THE CT SCAN ANGIOGRAPHY OF THE ABDOMEN AND PELVIS RESULT WAS: "THERE IS AN ACUTE LEFT ILIOPSOAS HEMATOMA, WITHOUT EVIDENCE FOR ACTIVE HEMORRHAGE." HEPARIN DRIP WAS THEN STOPPED, 2 UNITS OF PACKED RED BLOOD CELL (PRBC) WERE TRANSFUSED, AND COMPLETE BLOOD COUNT (CBC) LEVELS WERE MONITORED. THERE WERE NO OTHER INTERVENTIONS PER CUSTOMER'S REPORT. THE "HGB RESPONDED APPROPRIATELY TO TRANSFUSIONS. BPS (BLOOD PRESSURE) STABLE."
IT WAS REPORTED THAT DURING HANDOFF, HEPARIN (25,000 UNITS/250ML) WAS SCANNED TO PROGRAM THE INFUSION. PER REPORT, THE INFUSION SETTING WAS 13.44ML/HR. ("CORRECT RATE"); HOWEVER, THE PUMP RATE REPORTEDLY "SWITCHED BACK TO ORIGINAL ORDER OF "12 UNITS". FROM 7:17 TO 8:14, THE DEVICE REPORTEDLY INDICATED THAT IT INFUSED AT 13.44ML/HR.,12 UNITS. THE CUSTOMER STATED THAT "IT SHOULD HAVE BEEN 13.44ML/HR. AND 24 UNITS, "UNIT AND RATE SHOULD CHANGE SIMULTANEOUSLY". THE NURSE REPORTEDLY "NOTICED IT LATER AROUND ONE HOUR WHILE CHECKING ANTIXA (LEVEL) RESULTS AND CORRECTED". FOR AROUND ONE HOUR, THE PATIENT REPORTEDLY RECEIVED HALF DOSE OF THE HEPARIN THEY SHOULD HAVE RECEIVED. DUE TO THE EVENT, THE PROVIDER "HELD HEPARIN AS PATIENT'S HGB (HEMOGLOBIN LEVEL) DROPPED AND THE CT (SCAN) SHOWED THEY WERE HAVING BLEED". HOWEVER, THE CUSTOMER (ASSISTANT NURSE MANAGER) HAS INDICATED THAT "THE BLEED WAS NOT CAUSED BY THE EQUIPMENT ERROR BECAUSE THE ML/HR. WAS THE SAME." PER REPORT, THE PATIENT'S BLOOD PRESSURE WAS 97/62, HEMOGLOBIN 5.7, AND THE CT SCAN ANGIOGRAPHY OF THE ABDOMEN AND PELVIS RESULT WAS: "THERE IS AN ACUTE LEFT ILIOPSOAS HEMATOMA, WITHOUT EVIDENCE FOR ACTIVE HEMORRHAGE." HEPARIN DRIP WAS THEN STOPPED, 2 UNITS OF PACKED RED BLOOD CELL (PRBC) WERE TRANSFUSED, AND COMPLETE BLOOD COUNT (CBC) LEVELS WERE MONITORED. THERE WERE NO OTHER INTERVENTIONS PER CUSTOMER'S REPORT. THE "HGB RESPONDED APPROPRIATELY TO TRANSFUSIONS. BPS (BLOOD PRESSURE) STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 824055 | ALARIS SYSTEM | PUMP, INFUSION | FRN | CAREFUSION SD | 8100 | 10885403810015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | (B)(6). |