BD T34¿ SYRINGE PUMP
Report
- Report Number
- 2243072-2021-02875
- Event Type
- Malfunction
- Date Received
- December 7, 2021
- Date of Event
- November 9, 2021
- Report Date
- June 7, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FRN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS CAESAREA MEDICAL ELECTRONICS LTD. THIS SITE IS AN OEM MANUFACTURING SITE. 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. MEDICAL DEVICE EXPIRATION DATE: NA. 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.
INVESTIGATION SUMMARY: A T34 SYRINGE PUMP (S/N: (B)(6) ; S/W: NCAT10410C) WAS RECEIVED FOR INVESTIGATION AND THE EVENT LOG WAS DOWNLOADED. ADDITIONAL INFORMATION INDICATED THAT THE ACTUATOR WOULD NOT MOVE. A VISUAL INSPECTION OF THE PUMP IDENTIFIED THAT THE BATTERY COVER WAS MISSING. THE PUMP'S EVENT LOG WAS REVIEWED, AND THE FOLLOWING OBSERVATIONS WERE NOTED: THE EVENT LOG RECORDED USE FROM 14/JUL/2020 TO 06/SEP/2021. THE LAST INFUSION RECORDED IN THE EVENT LOG WAS STARTED ON 28/JUL/2020 AND WAS STOPPED ON THE SAME DAY SIX HOURS INTO THE INFUSION. DURING THE EVALUATION, THE PUMP WAS SUBJECTED TO THE FOLLOWING: AN INSPECTION OF THE PLUNGER ASSEMBLY AND MOTOR BLOCK DID NOT IDENTIFY ANY DEFECTS OR SIGNS OF DAMAGE. THE PRE-LOADING WAS ABLE TO BE COMPLETED SUCCESSFULLY IN THE RETURNED PUMP. THE SYRINGE TRAVEL TEST AND THE SYRINGE SENSOR TEST WERE COMPLETED SUCCESSFULLY. THE PUMP WAS POWERED ON INTO USER MODE AND WAS ABLE TO START MULTIPLE INFUSIONS WITHOUT ANY ISSUES. AN INTERNAL INSPECTION OF THE RETURNED PUMP DID NOT IDENTIFY ANY ANOMALIES. TESTING OF THE ELECTRICAL CONDUCTION OF THE MOTOR BLOCK, WHICH CONTAINS THE ACTUATOR, DID NOT IDENTIFY ANY ANOMALIES. THE PUMP WAS TESTED IN ACCORDANCE WITH THE TECHNICAL SERVICE MANUAL WITH CORRECT OPERATION, ALARM FUNCTIONALITY AND IN SPECIFICATION RESULTS RECORDED. A DEVICE HISTORY RECORD REVIEW IDENTIFIED THAT THE PUMP WAS MANUFACTURED IN APRIL 2012 WITH NO REWORK ACTIVITY BEING PERFORMED DURING THE BUILD PROCESS. THE LAST BD SERVICE ACTIVITY RAISED AGAINST THE PUMP WAS RECORDED IN AUG/2021 DURING WHICH THE MOTOR BLOCK, THE REAR ASSEMBLY AND THE FRONT CASE WERE REPLACED. FROM THE EVALUATION UNDERTAKEN NO FAULT WAS IDENTIFIED WITH THE PUMPS' SYRINGE PLUNGER ASSEMBLY AND THE ACTUATOR WAS MOVING WITH NO INTERRUPTIONS. A REVIEW OF PREVIOUS CUSTOMER ADVOCACY FEEDBACK IDENTIFIED THERE IS A LOW FREQUENCY OF REPORTS RELATED TO THE FEEDBACK ISSUE HOWEVER, THERE IS CURRENTLY NO TREND FOR REPORTS OF THIS NATURE. BD WILL CONTINUE TO TRACK AND TREND ISSUES OF A SIMILAR NATURE.
IT WAS REPORTED THAT THE BD T34¿ SYRINGE PUMP WAS DAMAGED AND COULDN'T FIT THE SYRINGE IN IT AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "S38218 ¿ THE MECHANISM FOR THE SYRINGE DOES NOT MOVE BACK ENOUGH FOR THE SYRINGE TO BE PLACED CORRECTLY."
IT WAS REPORTED THAT THE BD T34¿ SYRINGE PUMP WAS DAMAGED AND COULDN'T FIT THE SYRINGE IN IT AS A RESULT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "S38218 ¿ THE MECHANISM FOR THE SYRINGE DOES NOT MOVE BACK ENOUGH FOR THE SYRINGE TO BE PLACED CORRECTLY.".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1853516 | BD T34¿ SYRINGE PUMP | PUMP, INFUSION | FRN | BECTON DICKINSON | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |