BD ALARIS¿ EXTENSION SET
Report
- Report Number
- 2243072-2021-02817
- Event Type
- Malfunction
- Date Received
- November 24, 2021
- Date of Event
- October 19, 2021
- Report Date
- December 10, 2021
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- PMA / PMN Number
- K790108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
CORRECTION: THE CATALOG# WAS RECEIVED; THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET WAS BLOCKED DURING THE FLUSH AND LEAKED ONTO THE FLOOR. D.1. MEDICAL DEVICE BRAND NAME: BD ALARIS¿ EXTENSION SET D.3. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.2. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V G.5. PMA / 510(K)#: K790108.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
H6: INVESTIGATION SUMMARY SAMPLES 30914 AND MZ1000 WERE RETURNED FOR INVESTIGATION. THE SET WAS EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. A 10 ML BD SYRINGE FILLED WITH SALINE WAS ATTACHED TO THE SET AND ATTEMPTED TO FLUSH. THE SET WAS SUCCESSFULLY FLUSHED. THE CUSTOMER COMPLAINT THAT THE TUBING OCCLUDED COULD NOT BE REPLICATED. THE ROOT CAUSE COULD NOT BE DETERMINED BECAUSE THE ISSUE COULD NOT BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. H3 OTHER TEXT : SEE H10.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT THE BD ALARIS¿ EXTENSION SET WAS BLOCKED DURING THE FLUSH AND LEAKED ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIV WAS PLACED IN RIGHT SAPHENOUS FOR ANTIBIOTIC THERAPY. GENTAMICIN WAS CONNECTED AND ALARIS PUMP PROGRAMMED ACCORDINGLY. WHEN MEDICATION WAS COMPLETE, SALINE FLUSH WAS PLACED AND PROGRAMMED ALSO. HOWEVER, WHEN FLUSH WAS STARTED, THE ALARIS PUMP BEEPED/ALARMED OFF ALMOST IMMEDIATELY FOR OCCLUSION PATIENT SIDE. THIS RN TRIED TO FLUSH DISTAL MAX ZERO WITHOUT SUCCESS ATTEMPTED TO FLUSH BOTH PROXIMAL PORTS OF BIFUSE CONNECTOR WITHOUT SUCCESS. CHANGED DISTAL MAX ZERO AND FLUSHED ALSO WITHOUT SUCCESS. CALLED , RN TO HELP TAKE DRESSINGS OFF. FOUND CATHETER WAS KINKED BUT ABLE TO STRAIGHTEN AND FLUSH WITHOUT DIFFICULTY. NEW DRESSING WAS PLACED AND FLUSH WAS RESUMED. WHILE OBSERVING FLUSH INFUSION, THIS RN NOTED A "PUDDLE" OF FLUID ON THE FLOOR BENEATH THE ALARIS PUMP. THIS RN FELT THAT IT WAS THE ANTIBIOTIC ON THE FLOOR AND NOT THE SALINE FLUSH. THE ALARIS PUMP NEVER READ OFF OCCLUSION DURING THE ANTIBIOTIC INFUSION. THIS RN NOTIFIED , NNP REGARDING THIS MATTER. GENTAMICIN LEVEL BEEN ORDERED FOR EARLY AM."
IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ INFUSION SET WAS BLOCKED DURING THE FLUSH AND LEAKED ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIV WAS PLACED IN RIGHT SAPHENOUS FOR ANTIBIOTIC THERAPY. GENTAMICIN WAS CONNECTED AND ALARIS PUMP PROGRAMMED ACCORDINGLY. WHEN MEDICATION WAS COMPLETE, SALINE FLUSH WAS PLACED AND PROGRAMMED ALSO. HOWEVER, WHEN FLUSH WAS STARTED, THE ALARIS PUMP BEEPED/ALARMED OFF ALMOST IMMEDIATELY FOR OCCLUSION PATIENT SIDE. THIS RN TRIED TO FLUSH DISTAL MAX ZERO WITHOUT SUCCESS ATTEMPTED TO FLUSH BOTH PROXIMAL PORTS OF BIFUSE CONNECTOR WITHOUT SUCCESS. CHANGED DISTAL MAX ZERO AND FLUSHED ALSO WITHOUT SUCCESS. CALLED XXXXXX, RN TO HELP TAKE DRESSINGS OFF. FOUND CATHETER WAS KINKED BUT ABLE TO STRAIGHTEN AND FLUSH WITHOUT DIFFICULTY. NEW DRESSING WAS PLACED AND FLUSH WAS RESUMED. WHILE OBSERVING FLUSH INFUSION, THIS RN NOTED A "PUDDLE" OF FLUID ON THE FLOOR BENEATH THE ALARIS PUMP. THIS RN FELT THAT IT WAS THE ANTIBIOTIC ON THE FLOOR AND NOT THE SALINE FLUSH. THE ALARIS PUMP NEVER READ OFF OCCLUSION DURING THE ANTIBIOTIC INFUSION. THIS RN NOTIFIED XXXXX, NNP REGARDING THIS MATTER. GENTAMICIN LEVEL BEEN ORDERED FOR EARLY AM."
IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ INFUSION SET WAS BLOCKED DURING THE FLUSH AND LEAKED ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIV WAS PLACED IN RIGHT SAPHENOUS FOR ANTIBIOTIC THERAPY. GENTAMICIN WAS CONNECTED AND ALARIS PUMP PROGRAMMED ACCORDINGLY. WHEN MEDICATION WAS COMPLETE, SALINE FLUSH WAS PLACED AND PROGRAMMED ALSO. HOWEVER, WHEN FLUSH WAS STARTED, THE ALARIS PUMP BEEPED/ALARMED OFF ALMOST IMMEDIATELY FOR OCCLUSION PATIENT SIDE. THIS RN TRIED TO FLUSH DISTAL MAX ZERO WITHOUT SUCCESS ATTEMPTED TO FLUSH BOTH PROXIMAL PORTS OF BIFUSE CONNECTOR WITHOUT SUCCESS. CHANGED DISTAL MAX ZERO AND FLUSHED ALSO WITHOUT SUCCESS. CALLED XXXXXX, RN TO HELP TAKE DRESSINGS OFF. FOUND CATHETER WAS KINKED BUT ABLE TO STRAIGHTEN AND FLUSH WITHOUT DIFFICULTY. NEW DRESSING WAS PLACED AND FLUSH WAS RESUMED. WHILE OBSERVING FLUSH INFUSION, THIS RN NOTED A "PUDDLE" OF FLUID ON THE FLOOR BENEATH THE ALARIS PUMP. THIS RN FELT THAT IT WAS THE ANTIBIOTIC ON THE FLOOR AND NOT THE SALINE FLUSH. THE ALARIS PUMP NEVER READ OFF OCCLUSION DURING THE ANTIBIOTIC INFUSION. THIS RN NOTIFIED XXXXX, NNP REGARDING THIS MATTER. GENTAMICIN LEVEL BEEN ORDERED FOR EARLY AM."
IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ INFUSION SET WAS BLOCKED DURING THE FLUSH AND LEAKED ONTO THE FLOOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PIV WAS PLACED IN RIGHT SAPHENOUS FOR ANTIBIOTIC THERAPY. GENTAMICIN WAS CONNECTED AND ALARIS PUMP PROGRAMMED ACCORDINGLY. WHEN MEDICATION WAS COMPLETE, SALINE FLUSH WAS PLACED AND PROGRAMMED ALSO. HOWEVER, WHEN FLUSH WAS STARTED, THE ALARIS PUMP BEEPED/ALARMED OFF ALMOST IMMEDIATELY FOR OCCLUSION PATIENT SIDE. THIS RN TRIED TO FLUSH DISTAL MAX ZERO WITHOUT SUCCESS ATTEMPTED TO FLUSH BOTH PROXIMAL PORTS OF BIFUSE CONNECTOR WITHOUT SUCCESS. CHANGED DISTAL MAX ZERO AND FLUSHED ALSO WITHOUT SUCCESS. CALLED XXXXXX, RN TO HELP TAKE DRESSINGS OFF. FOUND CATHETER WAS KINKED BUT ABLE TO STRAIGHTEN AND FLUSH WITHOUT DIFFICULTY. NEW DRESSING WAS PLACED AND FLUSH WAS RESUMED. WHILE OBSERVING FLUSH INFUSION, THIS RN NOTED A "PUDDLE" OF FLUID ON THE FLOOR BENEATH THE ALARIS PUMP. THIS RN FELT THAT IT WAS THE ANTIBIOTIC ON THE FLOOR AND NOT THE SALINE FLUSH. THE ALARIS PUMP NEVER READ OFF OCCLUSION DURING THE ANTIBIOTIC INFUSION. THIS RN NOTIFIED XXXXX, NNP REGARDING THIS MATTER. GENTAMICIN LEVEL BEEN ORDERED FOR EARLY AM."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1769682 | BD ALARIS¿ EXTENSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |