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Model Number PM020-A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Unspecified Infection (1930)
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Event Date 05/26/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Method: the actual device was not returned.A review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.
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Event Description
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Fill volume: 550 ml.Flow rate: 4 ml/hr.Procedure: laparoscopic low anterior resection, complete mobilization of splenic flexure, omental pedicle flap to the pelvis.Cathplace: right and left upper abdomen.A report was received stating a possible infection from a catheter.The procedure was performed on (b)(6) 2016.The catheter was removed on (b)(6) 2016 and the infection was diagnosed at that time.The pump was not emptied when removed.The pump was connected to the patient during the surgery procedure before skin closure.The patient presented with fever; right upper abdomen catheter site redness.The catheter site was hard to touch, painful, hot to touch.A laboratory culture was not done.The patient was treated with oral augmentin, 500nmg, two times daily for 7-days.The patient responded to the treatment well.The patient had no fever and had marked decrease in swelling, tenderness and redness within 3-days.The patient was improving daily with no lasting effects the fascia at the small midline surgical incision was closed with a running #1 stratafix pds suture.The wound was pulse lavaged with a total of one liter acitracin irrigation.The skin incision was closed with running subcuticular 4-0 monocryl and dermabond was applied.The on-q pain catheter was placed through the peel-away sheaths, each loaded with 5 ml of 0.5% marcaine without epinephrine.There was no implant for this surgery.The length of the procedure was 187 minutes.No drains were placed.Prophylaxis antibiotics were used per standard.The surgeon believes the infection was related to the use of the device.
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Search Alerts/Recalls
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