MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT SVED; GENERAL SURGERY TRAY (KIT)

Model Number 51-SVED

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Death (1802); Unspecified Infection (1930)

Event Date 04/19/2019

Event Type  Death  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

Received notification from (b)(4) a distributor of the cardinal health negative pressure wound therapy device to (b)(6) center.They stated that they rehab facility was being inspected by the state and they were requesting our assistance with a negative pressure wound therapy device.The state was inspecting due to facility report of failure to comply with manufacturer's recommended dressing change schedule.On further inquiry it was learned that a patient was placed on a negative pressure wound therapy sved device/ 51-sved (serial number unknown) for a left above the knee amputation and the majority of the clinical team separated from the facility within a day or two of initiation of therapy.This included the director of nursing (don), treatment nurse and others from the clinical team.A new director of nursing was hired "about 3 weeks" later and upon reviewing patients, found a patient being treated with the sved device that had not had a dressing change to the treated wound since the initial application (approx 3 weeks).He reported a significant odor in the room and upon removal of the dressing found that the wound appeared grossly infected.He immediately sent patient to hospital for assessment.As reported by the director of nursing, patient expired at hospital on (b)(6) 2019.

Manufacturer Narrative

Mdr supplemental report being filed due to the type of report on the initial report in g7 was entered incorrectly and the follow-up box needed to be checked and a #1 was needed next to it in section g7, the event description in b5 was missing and the report number (1423537-2019-00322) was needed in g9.The correct type of report is now being submitted.No other changes to this report are required.

Event Description

Received notification from platinum a distributor of the cardinal health negative pressure wound therapy device to fountain blue health and rehab center.They stated that they rehab facility was being inspected by the state and they were requesting our assistance with a negative pressure wound therapy device.The state was inspecting due to facility report of failure to comply with manufacturer's recommended dressing change schedule.On further inquiry it was learned that a patient was placed on a negative pressure wound therapy sved device/ 51-sved (serial number unknown) for a left above the knee amputation and the majority of the clinical team separated from the facility within a day or two of initiation of therapy.This included the director of nursing (don), treatment nurse and others from the clinical team.A new director of nursing was hired "about 3 weeks" later and upon reviewing patients, found a patient being treated with the sved device that had not had a dressing change to the treated wound since the initial application (approx 3 weeks).He reported a significant odor in the room and upon removal of the dressing found that the wound appeared grossly infected.He immediately sent patient to hospital for assessment.As reported by the director of nursing, patient expired at hospital on b)(6) 2019.

Manufacturer Narrative

Mdr follow-up report being filed on the npwt 51-sved device that had been left on a patient with no dressing change to the treated wound since the initial application (approx 3 weeks) since device investigation results are available.Device npwt 51-sved was released for use on 09/26/2018.A historical review of the product was completed from (b)(6) 2018 to present and this is the only reported issue describing an issue attributed to patient neglect.Job router was reviewed without issue as device passed all testing and met all specification requirements.A sample was not received for evaluation.The user of the npwt 51-sved device confirmed they did not comply with the manufacturer's recommended dressing change schedule.The failure mode of the device was not attributed to a device failure but instead to patient neglect on behalf of the facility.Based on the investigation, there was no abnormal situation that had happened in production.Therefore, the root cause could not be attributed to production and no further action taken.The complaint information was shared with the relevant sectors within the manufacturing facility for their awareness and we will continue to monitor for this type of incident.

• Brand Name: NPWT SVED
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave; miami FL
• MDR Report Key: 8680613
• MDR Text Key: 147611565
• Report Number: 1423537-2019-00322
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 51-SVED
• Device Catalogue Number: 51-SVED
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 54