MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO COMPUTER SYSTEM EPICENTER FOR BDNLA; CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

Catalog Number 252752

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Sepsis (2067)

Event Date 07/10/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter address: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that due to use error there was a delay in analyzing a patient sample.The patient later expired.Initial report verbatim: ¿the time of service failed, during the weekend, just on wednesday afternoon the engineer came and due to the delay a girl died for this reason.The response time was too long.They told me that they came on monday and only did it on wednesday.By the nature of the samples we need a more active response.We couldn't do anything without the samples.¿ background: customer originally reported epicenter database issues on 04jul2021, service was performed on (b)(6) 2021 and the epicenter pc was restored.The customer reported that they believe the epicenter issue was caused by a facility electrical issue associated with the local power supply.The phoenix 100 instrument, which was connected to the epicenter, was working without error and the customer elected to delay the initialization of testing until the epicenter was also restored.Customer introduced the samples on wednesday (b)(6) after the epi was repaired.The customer reported that the patient expired saturday (b)(6) 2021 due to multi-organ failure, amine refractory septic shock, sepsis, 1st and 2nd degree burns in 54% of body surface area.

Manufacturer Narrative

H.6.Investigation: customer reported epicenter db corruption issues on (b)(6), 2021.Bd personnel restored epicenter pc (material: 252752, serial number (b)(6)) on (b)(6), 2021.Customer is reporting that because of the delay of service, a patient died.Additional information provided by customer: -there are regular electrical discharge issues at the facility due to its location between 2 maquila companies believed to be the cause of the issue with the site's power -customer chose to wait to enter the patient panel into the phoenix instrument until epicenter had been repaired rather than when the sample was received.-customer also indicated that for about the past 2 weeks, samples subrogated due to a shortage of material.During the investigation, it was determined that the phoenix instrument was operating correctly.The phoenix user's manual provides additional information on what available options and behaviors will occur on the phoenix when the attached epicenter is in error.This allows the customer to continue testing the sample in the instrument and the instrument will be able to produce a result that is viewable on the phoenix user interface.In this instance, the customer would have been able to provide the results of the patient sample prior to the connection to epicenter being restored, but would have been inconvenienced by having to manually report the result vs using the epicenter interface.The phoenix instrument was available and would have produced a result had the sample been entered into the instrument when received.It's also unclear whether this site contains a ups to reduce the number of power fluctuations that occur.This is not a confirmed complaint of a bd product as the phoenix instrument was available for sample entry.Recommendation is for this site to obtain ups to connect to the epicenter pc to reduce the number of power issues the pc incurs as a result of the site's power issues.Bd quality will continue to closely monitor for trends related to this complaint.H3 other text : see h.10.

Event Description

It was reported that due to use error there was a delay in analyzing a patient sample.The patient later expired.Initial report verbatim: ¿the time of service failed, during the weekend, just on wednesday afternoon the engineer came and due to the delay a girl died for this reason.The response time was too long.They told me that they came on monday and only did it on wednesday.By the nature of the samples we need a more active response.We couldn't do anything without the samples.¿ background: customer originally reported epicenter database issues on (b)(6) 2021, service was performed on (b)(6) 2021 and the epicenter pc was restored.The customer reported that they believe the epicenter issue was caused by a facility electrical issue associated with the local power supply.The phoenix 100 instrument, which was connected to the epicenter, was working without error and the customer elected to delay the initialization of testing until the epicenter was also restored.Customer introduced the samples on wednesday (b)(6), after the epi was repaired.The customer reported that the patient expired saturday (b)(6) 2021 due to multi-organ failure, amine refractory septic shock, sepsis, 1st and 2nd degree burns in 54% of body surface area.

• Brand Name: COMPUTER SYSTEM EPICENTER FOR BDNLA
• Type of Device: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• MDR Report Key: 12362743
• MDR Text Key: 268019369
• Report Number: 9614033-2021-00099
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 252752
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/26/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 09/29/2021
• Supplement Dates FDA Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention