Catalog Number 284504 |
Device Problem
Unknown (for use when the device problem is not known) (2204)
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Patient Problem
Unknown (for use when the patient's condition is not known) (2202)
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Event Date 07/30/2014 |
Event Type
Injury
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Event Description
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The tubing was used in a previous case, and when the regular scout nurse (junior staff) went to replace the tubing for the next case, a non regular but senior staff member over-ruled her, and insisted that it was a reusable item (as per a previous product code).This single use only tubing was therefore re-used on patient (b)(6), and again for another case, patient (b)(6).The regular nursing staff received in-service training at the time of the product changeover and regularly trained since, including written and oral communication.It is unknown if there has been an adverse effect on patients as yet, surgeon who was also informed of the incident on (b)(6) 2014, is to contact the patients and follow-up as appropriate.A formal incident report had been raised by the hospital and rep has discussed the issue with the director of clinical services.
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Manufacturer Narrative
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Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek; however, it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.
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Manufacturer Narrative
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The complaint device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Irrigation tubing product code 284504 can be used for the day providing it is used with patient outflow tubing containing a one way pillow valve.Reports are the customer used patient outflow tubing that did not contain a one way pillow valve.Our ifu states that the one day set may be used for multiple procedures during the same surgical day provided that proper set-up and tube changing procedures are followed in order to preserve sterility.The set-up procedure can be found in ifu-109076-kim starting on page 17.Page 19 discusses the setup of intermediary irrigation tube sets with one-way check valves in order to allow multiple uses of the one day set (in this case, tube set 284504).Without the check valve tubing is intended to be single use only.Therefore the root cause is determined to be the user not following ifu instructions during setup of tube sets.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Should any new information be received in regards to the patient¿s condition, this file will be reopened and updated at that time and a follow-up report will be filed.
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Event Description
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The tubing was used in a previous case, and when the regular scout nurse (junior staff) went to replace the tubing for the next case, a non regular but senior staff member over-ruled her, and insisted that it was a reusable item (as per a previous product code).This single use only tubing was therefore re-used on patient (b)(6), and again for another case, patient (b)(6).The regular nursing staff received inservice training at the time of the product changeover and regularly trained since, including written and oral communication.It is unknown if there has been an adverse effect on patients as yet, surgeon who was also informed of the incident on (b)(6) 2014, is to contact the patients and follow-up as appropriate.A formal incident report had been raised by the hospital and rep has discussed the issue with the director of clinical services.The following information was received from our affiliate via email on (b)(6) 2014; the proper set-up of the pump and tube sets was followed for the arthroscopic shoulder surgery.However there was no one way valve used and the inflow tubing was reused instead of being discarded as it should have been.Lot numbers of the tube set are unavailable.There is no update on the patient铠status.The surgeon was to inform the patient and have blood tests done, routine pre-op blood tests were normal.
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Search Alerts/Recalls
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