BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
Report
- Report Number
- 2243072-2021-02909
- Event Type
- Malfunction
- Date Received
- December 14, 2021
- Date of Event
- November 16, 2021
- Report Date
- January 27, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FPA
- PMA / PMN Number
- K944320
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS PUMP MODULE SMARTSITE INFUSION SET HAD ISSUES WITH MEDICINE FLOWING INTO THE PRIMARY BAG DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE WATCHED THE SOLUCORTEF FLOW UP INTO HER PRIMARY BAG¿.. LOOKS LIKE A DEFECTIVE BACK-CHECK VALVE." D.1. MEDICAL DEVICE BRAND NAME: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; D.4. MEDICAL DEVICE CATALOG #: 2426-0007; D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4); G.4. PMA / 510(K)#: K944320. H.6. INVESTIGATION: ONE PRIMARY TUBING (MODEL 2426-0007) AND ONE SECONDARY TUBING WERE RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT A NURSE WATCHED THE FLUID FLOW UP INTO THE THE PRIMARY BAG. THE SAMPLES WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. NO DEFECTS OR ABNORMALITIES WERE OBSERVED. FUNCTIONAL TESTING WAS PERFORMED BY USING A PRIMARY BAG FILLED WITH CLEAR SALINE WHICH WAS THEN USED TO PRIME THE SET. THE SECONDARY SET WAS CONNECTED TO A BAG FILLED WITH A BLUE DYE/WATER MIXTURE, AND THEN CONNECTED TO THE PRIMARY SET. THE SETS WERE SET UP IN A SECONDARY INFUSION CONFIGURATION WITH THE FLUID LEVEL OF THE SECONDARY BAG AT LEAST 9.5 INCHES HIGHER THAN THE PRIMARY BAG FLUID LEVEL, AND ALL OF THE CLAMPS CLOSED. THE SECONDARY SET WAS PRIMED WITH THE SECONDARY ROLLER CLAMP FULLY OPENED. FLUID FLOW WAS CONTROLLED USING THE PRIMARY ROLLER CLAMP. FLUID WAS FOUND TO BE FLOWING NORMALLY. NO BACK FLOW WAS OBSERVED. THE FAILURE WAS UNABLE TO BE REPLICATED, AND THE COMPLAINT COULD NOT BE VERIFIED. A ROOT CAUSE WAS UNABLE TO BE DETERMINED BECAUSE THE FAILURE WAS UNABLE TO BE REPLICATED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MODEL 2426-0007 BECAUSE A LOT NUMBER IS UNKNOWN AND WAS UNABLE TO BE IDENTIFIED. H3 OTHER TEXT : SEE H.10.
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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PUMP MODULE SMARTSITE INFUSION SET HAD ISSUES WITH MEDICINE FLOWING INTO THE PRIMARY BAG DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE WATCHED THE SOLUCORTEF FLOW UP INTO HER PRIMARY BAG¿.. LOOKS LIKE A DEFECTIVE BACK-CHECK VALVE."
IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET HAD ISSUES WITH MEDICINE FLOWING INTO THE PRIMARY BAG DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NURSE WATCHED THE SOLUCORTEF FLOW UP INTO HER PRIMARY BAG¿.. LOOKS LIKE A DEFECTIVE BACK-CHECK VALVE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1901147 | BD ALARIS PUMP MODULE SMARTSITE INFUSION SET | INTRAVASCULAR ADMINISTRATION SET | FPA | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |