MAUDE Adverse Event Report: CARDINAL HEALTH NPWT FACILITY 6701132 DAILY RENTAL; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	SVEDRENT
Health Effect - Clinical Codes	Fever (1858); High Blood Pressure/ Hypertension (1908); Test Result (2695)
Date of Event	01/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device released from qa to stock on 06/04/2019.No service reports were available at the time of this review.Job router was reviewed without issue.Device passed all tests.Device history record for serial number (b)(4) was reviewed and there were no issues found.Device passed all manufacturing test descriptions.It was noted in the complaint that a canister valve was wedged in the device coupler, this occurrence is usually an indication of damage by user misuse.A sample was not returned for evaluation.It was stated that the patient will be keeping the device and there is no clear indication of when it will be returned.If device is returned at a later date a follow up to this report will be performed.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but we will continue to monitor the trend of this type of incident.
Event or Problem Description
It was reported to cardinal health, that our customer¿s patient at the short term rehab facility who had a negative pressure wound device applied/6701132 went to an er with a high fever, high blood pressure, and an elevated white blood cell count.The power to the device was turned off when the patient arrived at the er.The er nurse stated that she was told the device was off because the dressing was done incorrectly, but the er nurse stated the dressing looked intact but that the canister would not lock into place.Cardinal health rep indicated that maybe the device had been dropped and one of the canister pegs broke off into the device.The er nurse looked at that part of the device and did say that a peg was broken off into the machine.The er nurse removed the existing wound dressing and replaced it with an alternate dressing since no further supplies from the patient were available and there was no way of knowing how long the device had been turned off.Our customer could not pinpoint the cause of the patient¿s symptoms at the time of the er admission.

• Brand Name: 6701132 DAILY RENTAL
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): CARDINAL HEALTH NPWT FACILITY; 14201 nw 60th ave.; miami lakes FL
• MDR Report Key: 9673582
• Report Number: 1423537-2020-00408
• Device Sequence Number: 2664111
• Product Code: OMP
• UDI-Device Identifier: 10885380097454
• UDI-Public: 10885380097454
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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
• Operator of Device: Health Professional
• Device Model Number: SVEDRENT
• Device Catalogue Number: SVEDRENT
• Device Lot Number: 19887
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2020
• Initial Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization