BD ALARIS¿ SECONDARY SET
Report
- Report Number
- 2243072-2023-00474
- Event Type
- Malfunction
- Date Received
- March 24, 2023
- Date of Event
- March 3, 2023
- Report Date
- June 1, 2023
- Manufacturer
- SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 50885403234741
- PMA / PMN Number
- K790582
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-MAY-2023. INVESTIGATION SUMMARY: ONE SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM. THE SET WAS SEPARATED UPON RECEIPT WHICH HAS VERIFIED THE CUSTOMER'S COMPLAINT. THE UPPER SILICONE PORTION OF TUBING THAT IS INSERTED INTO PUMP WAS ANALYZED UNDER A HIGH POWER DIGITAL MICROSCOPE AND THERE SEEMED TO BE A DEFORMATION PRESENT IN THE TUBE. THE MANUFACTURER WAS CONTACTED AND THE ROOT CAUSE HAS BEEN DETERMINED TO BE AN IMPROPER ASSEMBLY MOST LIKELY DUE TO CAMERA USED TO PRODUCED SETS BEING MISALIGNED AT TIME OF ASSEMBLY. THE CAMERA HAS SINCE BEEN ALIGNED PROPERLY AND A FIXTURE HAS BEEN ADDED TO THE BENCH TO HELP INSURE THE ALIGNMENT OF SETS FOR PROPER INSERTION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 11448964 LOT NUMBER 22053234 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE BUILD OF THIS SET.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET THE TUBING SEPARATED AT THE PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS ALSO A PUMP SEGMENT SEPARATION RECEIVED." D1: MEDICAL DEVICE BRAND NAME: BD ALARIS¿ SECONDARY SET. D4: UDI # (B)(4). D4: CATALOG #11448964. D4: MEDICAL DEVICE LOT #: 22053234 . D4: MEDICAL DEVICE EXPIRATION DATE: 19-MAY-2025. G.5. PMA / 510(K)#: K790582. H4: DEVICE MANUFACTURE DATE: 10-MAY-2022.
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 FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES 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¿ SECONDARY SET THE TUBING SEPARATED AT THE PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS ALSO A PUMP SEGMENT SEPARATION RECEIVED."
IT WAS REPORTED THAT THE BD ALARIS¿ SECONDARY SET THE TUBING SEPARATED AT THE PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS ALSO A PUMP SEGMENT SEPARATION RECEIVED."
IT WAS REPORTED THAT THE UNSPECIFIED BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET TUBING SEPARATED AT THE PUMP SEGMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS ALSO A PUMP SEGMENT SEPARATION RECEIVED."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 584388 | BD ALARIS¿ SECONDARY SET | INTRAVASCULAR ADMINISTRATION SET | FPA | SISTEMAS MEDICOS ALARIS, S.A. DE C.V. | 11448964 | 22053234 | 50885403234741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |