MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO WITH SOFT PORT 15X20CM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Catalog Number 66801362

Device Problem Pumping Problem (3016)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

It was reported that the machine stopped after two days of treatment.No patient harm reported.

Manufacturer Narrative

Device was not evaluated due to it was not returned for investigation.Investigation results: we have now completed our investigation into the reported complaint.As of today, no product return or further information for this complaint has become available preventing a more thorough investigation.If the product becomes available in the future, this case will be reopened.A device history record review was carried out for the batch number supplied.This confirmed that the product had been manufactured in accordance with defined procedures and specifications and there was no record of any problems or deviations occurring during manufacturing of this product in relation to the reported issue.Each pump is functionally tested by the supplier before shipment to smith & nephew.Any pump which fails to meet the predetermined acceptance criteria is rejected.As this pump has been released for sale, it can be confirmed that the device has passed all functional testing.On this occasion we are unfortunately unable to reach a definitive root cause of the problem due to insufficient information available for the device in question, however smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.

• Brand Name: PICO WITH SOFT PORT 15X20CM
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-8N ; UK HU3 28N
• MDR Report Key: 7412827
• MDR Text Key: 104957988
• Report Number: 8043484-2018-00080
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 66801362
• Device Lot Number: 1723
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 06/09/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1