MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY NPWT SVED THERAPY DEVICE; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number 6701132

Device Problems Device Alarm System (1012); Overheating of Device (1437); Suction Problem (2170); Suction Failure (4039)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/21/2021

Event Type  malfunction  

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

Customer reported that when the power was turned on the device, there was no suction even after troubleshooting.The device was not alarming to alert there was no suction.New device was obtained.There was no injury or adverse event reported.

Manufacturer Narrative

Supplemental report being filed since sample device received for evaluation.Device released from qa to stock on 10/27/2021.Job router was reviewed without issue, service records were reviewed without issues.Serial number (b)(6) device passed all tests.From the sample investigation, it was discovered that the root cause was overheating which damaged tubing and wires causing pump failure.Capa-ma029-01812 was opened and an investigation into the overheating complaints was conducted.The following corrective actions were identified to address the root causes identified in the capa: these corrective actions are planned to be completed by december 2021.Ifu for sved device to be updated to include the warning for overheating and no direct contact of the device with patient.Update the service procedure to consider changing the motor is the motor has serviced more than 2000 hours.Implement the service timer recording in the service procedure and forms to determine when to change the motor once the serviceable life has been exhausted.Install relay cut off mechanism at appropriate threshold temperature that will cut off the current to the motor in cases when motor may draw excessive current leading to overheating effect.Cardinal health will continue to monitor the trend of this type of incident.

• Brand Name: NPWT SVED THERAPY DEVICE
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer (Section G): CARDINAL HEALTH NPWT FACILITY; 8322 eagle palm drive; riverview FL 33578
• Manufacturer Contact: patricia tucker ; 1500 waukegan rd; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 13282499
• MDR Text Key: 291752229
• Report Number: 1423537-2022-00717
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6701132
• Device Catalogue Number: 6701132
• Device Lot Number: 14205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 49 KG