ALARIS PUMP MODULE ADMINISTRATION SET
Report
- Report Number
- 9616066-2019-02970
- Event Type
- Malfunction
- Date Received
- October 24, 2019
- Date of Event
- June 12, 2019
- Report Date
- September 27, 2019
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- UDI-DI
- 07613203021012
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
CONTINUED FROM D.11-DELTEC PORT-A-CATH GRIPPER PLUS SAFETY NEEDLES 20G X .75 MODEL: 21-2767-24, LOT: 3581423, EXPIRATION (B)(6) 2023. ; PORT-A-CATH ADDITIONAL MEDWATCH INFORMATION PROVIDED. ADDITIONAL PATIENT INFORMATION: ETHNICITY: NOT HISPANIC/LATINO, RACE: WHITE, DIAGNOSIS: DISARTICULATED RIGHT HIP DUE TO OSTEOSARCOMA TO DISTAL THIGH MASS ON 01/07/2019. BILATERAL PULMONARY METASTATIC DISEASE.
THE CUSTOMER¿S REPORT THAT THE TUBING SET OCCLUDED WAS NOT CONFIRMED. THE CUSTOMER¿S REPORT OF A LEAK AT THE DISTAL PORT WAS CONFIRMED. THE SET WAS VISUALLY INSPECTED FOR KINKS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OF THE SET NOTED PUNCTURE ON THE TOP OF THE BOTTOM SMARTSITE VALVE'S PISTON. ALSO OBSERVED ON THE VALVE WAS WHITE CLOUDINESS WITHIN THE BODY; ALONG THE BOTTOM OF THE CAP. NO OTHER DAMAGE OR ISSUE WAS OBSERVED. EXAMINATION UNDER MAGNIFICATION OF THE VALVE PISTON OBSERVED PUNCTURES WHICH FORMED A CIRCULAR-LIKE PATTERN. FUNCTIONAL TESTING CONFIRMED LEAKING FROM THE BOTTOM SMARTSITE VALVE PISTON. NO OTHER LEAKS AND NO OCCLUSIONS WERE OBSERVED. THE CAUSE WAS DUE TO A DAMAGED SMARTSITE VALVE PISTON. THE ROOT CAUSE OF THE DAMAGE WAS NOT IDENTIFIED.
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE APPROXIMATELY SIX MONTHS POST PORT PLACEMENT IN THE PATIENT'S LEFT CHEST WALL, THE DISTAL MED PORT ON THE IV ADMINISTRATION TUBING SET WAS OCCLUDED AND UNABLE TO FLUSH. UPON ASSESSMENT, IT WAS IDENTIFIED THAT THE BLUE LUER LOCK CONNECTION SITE ON THE DISTAL PORT LEAKED AND APPEARED TO BE DISCOLORED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT. RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM CUSTOMER WHICH STATES, ¿DURING ROUTINE MAINTENANCE, DISTAL MED PORT ON PRIMARY FLUID TUBING ACCESSED AND ATTEMPTED TO FLUSH WITH 0.9% NS. LINE UNABLE TO BE FLUSHED FROM THIS PORT. RN MOVED TO FLUSH PROXIMAL PORT OF VAC WITH NO RESISTANCE. PRIMARY TUBING REMOVED FROM PATIENT AND UPON INSPECTION NOTICED DISTAL PORT OF PRIMARY TUBING TO BE DISCOLORED INSIDE THE TUBING AND LEAKING FROM THE BLUE LURE LOCK CONNECTION SITE. NO INJURY TO PATIENT NOTED. PORT IMPLANTED (B)(6) 2018 TO LEFT CHEST USING 14 G NEEDLE, SCV WITH FLOURO ASSIST. ROUTINE NEEDLELESS CONNECTOR CHANGE ON (B)(6) 2019, LEAK OCCURRED ON (B)(6) 2019."
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE APPROXIMATELY SIX MONTHS POST PORT PLACEMENT IN THE PATIENT'S LEFT CHEST WALL, THE DISTAL MED PORT ON THE IV ADMINISTRATION TUBING SET WAS OCCLUDED AND UNABLE TO FLUSH. UPON ASSESSMENT, IT WAS IDENTIFIED THAT THE BLUE LUER LOCK CONNECTION SITE ON THE DISTAL PORT LEAKED AND APPEARED TO BE DISCOLORED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT. RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM CUSTOMER WHICH STATES, ¿DURING ROUTINE MAINTENANCE, DISTAL MED PORT ON PRIMARY FLUID TUBING ACCESSED AND ATTEMPTED TO FLUSH WITH 0.9% NS. LINE UNABLE TO BE FLUSHED FROM THIS PORT. RN MOVED TO FLUSH PROXIMAL PORT OF VAC WITH NO RESISTANCE. PRIMARY TUBING REMOVED FROM PATIENT AND UPON INSPECTION NOTICED DISTAL PORT OF PRIMARY TUBING TO BE DISCOLORED INSIDE THE TUBING AND LEAKING FROM THE BLUE LURE LOCK CONNECTION SITE. NO INJURY TO PATIENT NOTED. PORT IMPLANTED 12/05/2018 TO LEFT CHEST USING 14 G NEEDLE, SCV WITH FLOURO ASSIST. ROUTINE NEEDLELESS CONNECTOR CHANGE ON 6/11/2019, LEAK OCCURRED ON 6/12/2019."
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE APPROXIMATELY SIX MONTHS POST PORT PLACEMENT IN THE PATIENT'S LEFT CHEST WALL, THE DISTAL MED PORT ON THE IV ADMINISTRATION TUBING SET WAS OCCLUDED AND UNABLE TO FLUSH. UPON ASSESSMENT, IT WAS IDENTIFIED THAT THE BLUE LUER LOCK CONNECTION SITE ON THE DISTAL PORT LEAKED AND APPEARED TO BE DISCOLORED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT. RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM CUSTOMER WHICH STATES, ¿DURING ROUTINE MAINTENANCE, DISTAL MED PORT ON PRIMARY FLUID TUBING ACCESSED AND ATTEMPTED TO FLUSH WITH 0.9% NS. LINE UNABLE TO BE FLUSHED FROM THIS PORT. RN MOVED TO FLUSH PROXIMAL PORT OF VAC WITH NO RESISTANCE. PRIMARY TUBING REMOVED FROM PATIENT AND UPON INSPECTION NOTICED DISTAL PORT OF PRIMARY TUBING TO BE DISCOLORED INSIDE THE TUBING AND LEAKING FROM THE BLUE LURE LOCK CONNECTION SITE. NO INJURY TO PATIENT NOTED. PORT IMPLANTED (B)(6) 2018 TO LEFT CHEST USING 14 G NEEDLE, SCV WITH FLOURO ASSIST. ROUTINE NEEDLELESS CONNECTOR CHANGE ON (B)(6) 2019, LEAK OCCURRED ON (B)(6) 2019."
THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
IT WAS REPORTED THAT DURING ROUTINE MAINTENANCE APPROXIMATELY SIX MONTHS POST PORT PLACEMENT IN THE PATIENT'S LEFT CHEST WALL, THE DISTAL MED PORT ON THE IV ADMINISTRATION TUBING SET WAS OCCLUDED AND UNABLE TO FLUSH. UPON ASSESSMENT, IT WAS IDENTIFIED THAT THE BLUE LUER LOCK CONNECTION SITE ON THE DISTAL PORT LEAKED AND APPEARED TO BE DISCOLORED. THE CUSTOMER FURTHER STATED THAT THERE WERE NO ADVERSE EFFECTS CAUSED TO THE PATIENT FROM THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029079 | ALARIS PUMP MODULE ADMINISTRATION SET | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | 2420-0007 | 07613203021012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR | RED CAP, THERAPY DATE UNK.| THERAPY DATE (B)(6) 2019. |