MAUDE Adverse Event Report: BECTON DICKINSON KIT TABLET; INFUSION SAFETY MANAGEMENT SOFTWARE

Model Number	516704
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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.(b)(4).
Event or Problem Description
It was reported that the kit tablet recorded the incorrect doses.This occurred 8 separate times during use.The following information was provided by the initial reporter: "dose mismatch case #(b)(6): time 09:00 a.M., sensor #(b)(4).At 07:45 - propofol -should have been zero.Was ns flush, button clicked wrong.At 07:46 - fentanyl -given 100mcg.At 07:47 - propofol -given 160mg.At 08:09 - cefazolin -given 500mg.At 08:10 - cefazolin-given 1000mg.(total 2000mg).At 19:31 - vecuronium - given 3mg.Case #(b)(6): time 12:40 p.M., sensor #(b)(4).At 12:20 - propofol -given 180mg.At 13:02 - vecuronium - given 2mg.Unable to rely on instrument measurements".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 20028t05, d4: medical device expiration date: na, h4: device manufacture date: 2020-02-27.H6: investigation summary: no photos or samples were received by our quality team for evaluation.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the system preformed as designed.
Event or Problem Description
It was reported that the kit tablet recorded the incorrect doses.This occurred 8 separate times during use.The following information was provided by the initial reporter: "dose mismatch case # (b)(4): time 09:00 a.M.Sensor #9365.07:45 - propofol -should have been zero.Was ns flush, button clicked wrong.07:46 - fentanyl -given 100mcg.07:47 - propofol -given 160mg.08:09 - cefazolin -given 500mg.08:10- cefazolin-given 1000mg.(total 2000mg) 19:31 vecuronium - given 3mg.Case # (b)(4): time 12:40 p.M.Sensor #9400: 12:20 - propofol -given 180mg.13:02 vecuronium - given 2mg.Unable to rely on instrument measurements.".

• Brand Name: KIT TABLET
• Common Device Name: INFUSION SAFETY MANAGEMENT SOFTWARE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11386665
• Report Number: 2243072-2021-00624
• Device Sequence Number: 19829702
• Product Code: PHC
• UDI-Device Identifier: 00382905167041
• UDI-Public: 00382905167041
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K182092
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 516704
• Device Catalogue Number: 516704
• Device Lot Number: 20028T05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1