MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving an unknown medication via an implanted pump.On (b)(6) 2020 it was reported that the hcp was working with an a810 tablet and had interrogated the patient¿s pump.Post interrogation, the screen went blank and they had to reboot the tablet.They used a second tablet on the same patient and the same issue occurred.They then used the same tablets on another patient and the tablets worked just fine.The tablet¿s software had been updated to the most current software 1 week ago.It was unknown by the reporter if the tablet had gone into sleep mode.The status of the batteries and charging of the device were also unknown.It was recommended that the hcp contact technical services directly.No patient symptoms/complications were reported.Additional information was received on 31-aug-2020 from the hcp directly who reported that they were getting code 0x76cd26a9 on both tablets.The serial numbers of the tablets being used were r32j60052hk & r32j5001wam and both were updated last week to the 1.1.342 app version.Per the hcp, they were only getting this code with the one patient.When they would interrogate the pump, the initial "interrogating pump, communication in progress" would get to 100% then the screen went blank and displayed the code above.They went to interrogate another patient's pump and they did not get this message screen.The hcp confirmed they did not have an 8840 programmer and they were not able to interrogate this patient¿s pump.The hcp powered down the tablet; powered it back on; interrogated the pump and serial # r32j60052hk populated with code 0x2b38e750.The performance logs, audit logs, and logs for both tablets were obtained during the call and attached to the file.No further complications have been reported as a result of this event.Additional information was received from a representative on 2020-sep-02.It was reported that the clinic successfully filled the pu mp on 2020-aug-31 but were unable to update the reservoir since they couldn't interrogate the pump.Other considerations for updating were reviewed.No further complications were reported.

Event Description

Additional information from the healthcare provider via a device manufacturer representative was received regarding important patient demographics was reported.

Manufacturer Narrative

Concomitant medical products: product id a810,serial# unknown, product type software.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6) 2020 from a company representative who reported that he was unable to read the pump su ccessfully with an 8840 clinician programmer either.He tried multiple times and without notes or logs checked, but while it seemed like telemetry was complete, he was unable to read any information or make any changes.Because the pump was close to eos (end of service), they would look at trying to get it replaced soon.During the call it was reviewed that the pump will start non-critically alarming when it calculates that it's at the low reservoir and then the critical alarm will start once it thinks it's empty, but the ptm (personal therapy manager) will still allow the patient to give a bolus.

Manufacturer Narrative

H3: the pump was returned and analysis found a corruption in the system event log causing the clinician programmers (tablet and 8840) to crash.This device issue is known and documented in the labeling per ma04279a071 ¿ n¿vision clinician programmer with software synchromed ii infusion systems.Continuation of d10: product id: a810, product type: software.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 10489579
• MDR Text Key: 214635034
• Report Number: 3004209178-2020-15335
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 01/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."; "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 125