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Catalog Number UNKNOWN |
Device Problems
Energy Output Problem (1431); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017); Insufficient Flow or Under Infusion (2182); Biocompatibility (2886); No Flow (2991); Temperature Problem (3022)
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Patient Problems
Pressure Sores (2326); Skin Tears (2516)
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Event Type
Injury
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
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Event Description
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It was reported that the nurse just removed pads from patient and there was a large blister wound and tearing noted on the skin.Nurse was trying to determine if there was something missed on their end.The patient was maintaining target temperature so the device was no longer needed.Nurse stated patient had been off & on this device for the last month with extended use.It was noted that the nurse always recommend frequent and regular skin checks.The nurse walked through accessing event log.At (b)(6) 1:44 0014 treatment stopped, at (b)(6) midnight 0052 extended period of cold water, at (b)(6) 0014 treatment stopped, 0045 ac power lost, 0014 treatment stopped 2 times, 0003 water reservoir low 2 times, 0053 prolonged cold water exposure occurred 8 times, (b)(6) 0052 extended period of cold water alert occurred every hour until 11:48, (b)(6) 11:48 alarm 0053 prolonged cold water exposure, (b)(6) 4:00 0052 extended period of cold water, (b)(6) 5:00 0052 extended period of cold water, (b)(6) 8:00 0045 ac power lost, (b)(6) 0052 extended period of cold water exposure occurred 6 times.Explained to nurse that the 0052 extended period of cold water was an alert noting that the water temperature had been below 10c for at least 8 of the previous 10 hrs.The alert would recur after one hour if the condition continued.This alert was a safety alert and diligent skin check should be performed.It was explained that prolonged cold water exposure alarm occurred after the 0052 alert has been issued 11 times.It was a safety alarm and alarms stop therapy.The nurse would have to restart the therapy after this alarm occurs.It was also reported that it sounded like an education issue on their end.Noted.Nurse stated that the staff needed education and understanding that they could not ignore alarms.She asked how often pads should be changed and i noted we recommend the pads are changed every 5 days with diligent skin checks.Told nurse i would reach out to her clinical manager so that he could touch base about future training.As per follow up information, therapy was discontinued.The wound care team looked at the patients skin and is putting silver tone cream on it twice a day.The pads were disposed of after use.Per additional information received via phone on 22jul2020, the wound is treated with silvadene ointment and xeroform dressing changes twice daily.
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Event Description
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It was reported that the nurse just removed the pads from the patient and there was a large blister wound and tear noted on the skin.The nurse was trying to determine whether there was something missed on their end.The patient was maintaining the target temperature, so the device was no longer needed.The nurse stated that the patient had been off on the device for the last month with the extended use.It was noted that the nurse always recommend frequent and regular skin checks.The nurse walked through the accessing event log.The treatment was stopped, at (b)(6) midnight 0052 extended period of cold water, at( b)(6) 0014 treatment stopped, 0045 ac power lost, 0014 treatment stopped 2 times, 0003 water reservoir low 2 times, 0053 prolonged cold water exposure occurred 8 times, (b)(6) 0052 extended period of cold water alert occurred every hour until 11:48, (b)(6) 11:48 alarm 0053 prolonged cold water exposure, (b)(6) 4:00 0052 extended period of cold water, (b)(6) 5:00 0052 extended period of cold water, 27jun 8:00 0045 ac power lost, 6/25 0052 extended period of cold water exposure occurred 6 times.Ms&s explained the nurse the 0052 extended period of cold water was an alert noting that the water temperature had been below 10c for at least 8 of the previous 10 hrs.The alert would recur after one hour.If the condition continued.The alert was a safety alert and diligent skin check should be performed.It was explained that the prolonged cold water exposure alarm occurred after the 0052 alert has been issued 11 times.It was a safety alarm and the alarms stopped the therapy.The nurse would have to restart the therapy after the alarm occurs.It was also reported that it sounded like an education issue on their end.The nurse stated that the staff needed education and understanding that they could not ignore the alarms.The nurse asked how often the pads should be changed and noted ms&s recommended the pad change for every 5 days with the diligent skin checks.Ms&s told the nurse they would reach out to clinical manager so that they could touch the base about the future training.As per the follow-up information, the therapy was discontinued.The wound care team looked at the patient's skin and put the silver tone cream on it twice a day.The pads were disposed off after the use.Per additional information received via phone on (b)(6) 2020, the wound was treated with the silva dene ointment and xeroform dressing changed twice daily.
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Manufacturer Narrative
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The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to ¿materials that were contacting the patient¿s intact skin are not biocompatible.¿ it was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number was unknown, therefore, the device history record could not be reviewed.The product catalog number and lot number for this device was unknown.Therefore, bd was unable to determine the associated labeling to review.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.
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Search Alerts/Recalls
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