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On (b)(6) the wound vac was alarming and the caregiver couldn't get it to stop.Caregiver was instructed to call technical support to assist with trouble shooting.Caregiver called back about 2 hours later, and indicated that she had not connected two of the connections correctly and the pump was now working.The patient's wife called on monday (b)(6) to let me know her husband had to have the rest of his leg amputated because the 2 pumps we took would not suction.She stated that after about 5 days she said nothing was being suctioned from the first pump and she had an rn from (b)(6) go in and at that point the pump was switched out for a second pump.After about a day the second pump was not suctioning any debris out either, and the patient was not sent back to dr [redacted], vascular surgeon with (b)(6).Patient's wife stated that when foam was removed, the puss and debris flowed out because neither of the pumps they were provided worked and led to her husband having to have the rest of his leg amputated.When looking and both pumps, she also stated that either the dr or home health noticed our expired maintenance stickers on the back.
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This medical device report (mdr) is being submitted by smith & nephew as a result of a retrospective review of complaints, including adverse events, as part of corrective and remediation actions following the issuance of the 483 issued november 26, 2013 to smith & nephew, inc.(b)(4).Smith & nephew is performing a two-year retrospective review of complaint files to re-assess reportability criteria and reporting decisions made for complaints recorded during the time period under review.This complaint has been re-assessed in accordance under the provisions of 21cfr 803.50 and deemed reportable as an mdr.We are submitting one (1) initial, 30 day report, medwatch fda form 3500a, for a purported device malfunction which occurred while using the renasys go negative pressure wound therapy device.Two renasys go negative pressure wound therapy devices were received for evaluation at the smith & nephew service center.During evaluation of the device, the pump failed the calibration test due to a leak at the inlet port where the canister connects to the pump.A possible cause is damage to the inlet port itself or to the o-ring that surrounds the port.Based on information received from the complainant, this device was functioning correctly at the time of the incident as the complainant indicated to smith & nephew the device¿s alarm was functioning as intended.This was confirmed by smith & nephew with the complainant at the time of the trouble-shooting activity.It was determined the customer had an incorrect set up of the device causing continuous alarming.During evaluation of the device, all performance and safety tests were conducted and acceptable.An expired maintenance sticker was noted on this device.This is not a sticker applied by smith & nephew.Information on the sticker indicates that it may have been applied by (b)(6).The renasys go is a portable negative pressure wound therapy device.It is indicated for patients who would benefit from a suction device to help the promotion of wound healing by removing irrigation and body fluids, wound exudate and infectious materials.The precautions within the instructions for use include, in part, that infected wounds may require more frequent dressing changes, and regular monitoring of the wound must be maintained to check for signs of infections.The instructions for use also states that if there is any sign of systemic infection or advancing infection at the wound site, the clinician should be contacted immediately.The reported information does not indicate relevant information about wound monitoring and dressing changes.The reported information does indicate that an alarm was triggered by the device, which supports that the device was working as intended.Smith & nephew has issued (b)(4) to initiate renasys product labelling updates.These labelling updates will provide enhanced information on the functionality of the alarms as they relate to the design of the device, and scenarios than can occur in clinical settings which may impact alarm functionality.
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