MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 14 15CM X 15CM US CTN1; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number	66022045
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during npwt, the pico 14 15cm x 15cm pump had all four lights stay lit.The treatment was completed with another pump.No patient injury or other complications were reported.
Additional Manufacturer Narrative
We have now concluded our investigation for the complaint received.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.The complaint history file does not contain further instances/related events of the reported event.The devices were intended for use in treatment and were returned for evaluation.An initial visual inspection did not identify any issues.When fresh batteries were inserted into the devices all indicator lights were solidly illuminated and the devices did not function.No performance data could be extracted from the devices which confirmed a relationship between the event and the devices.The investigation has been concluded as a ¿software problem¿.Further actions by smith and nephew are ongoing at this stage.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
Additional Manufacturer Narrative
H10.The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.The loss of negative pressure wound therapy due to an inoperative or 'stopped' pump will not directly cause or contribute to serious injury or death as the pico dressing can revert to managing the wound as a standard multilayer dressing.No risk to patient safety is anticipated.This event is considered not reportable pursuant to 21 cfr part 803.

• Brand Name: PICO 14 15CM X 15CM US CTN1
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11712133
• Report Number: 8043484-2021-00918
• Device Sequence Number: 14514154
• Product Code: OMP
• UDI-Device Identifier: 05000223495411
• UDI-Public: 5000223495411
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K191760
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 66022045
• Device Lot Number: 1950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/11/2021; 08/04/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/18/2021; 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1