Model Number CNS000004 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problem
Unspecified Infection (1930)
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Event Date 11/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The goldtrace was tested for biocompatibility and passed all test.We are investigating the complaint and gathering more information to determine what could have caused the infection on the patient.
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Event Description
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Hospital narrative: "this is to inform you that our delivery unit has informed valvira, the finnish national registry that we have faced problems with goldtrace iu-scalp.The insertion site of the scalp was infected in 3 children, from whom 2 received iv antibiotics and one was treated with local antibiotics.In our information to valvira we have also described that the midwives and doctors have experienced more challenges to place the scalp electrode than with our previous electrodes.".
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Event Description
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Hospital narrative: "this is to inform you that our delivery unit has informed (b)(6) that we have faced problems with goldtrace iu-scalp.The insertion site of the scalp was infected in 3 children, from whom 2 received iv antibiotics and one was treated with local antibiotics.In our information to (b)(6) we have also described that the midwives and doctors have experienced more challenges to place the scalp electrode than with our previous electrodes.".
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Manufacturer Narrative
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Unfortunately, the device was not returned, therefore the device was not able to be examined, and the lot number was not confirmed.It was reported that the electrode was difficult to place and that there were 3 cases of infant's getting infections at the removal site.It was not reported whether the electrode was removed as stated in the ifu.The instructions for removal in the ifu reads as follows: "remove spiral needle by grasping electrode wires as close to fetal presenting part as possible and twist counter-clockwise until free from presenting part".If the electrode is excessively torqued during (e.G.Rotated > 1 ½ turns clockwise) application to the presenting part or if the electrode was rotated in the incorrect direction when removing from the scalp.Based on the information reported, i feel that the clinicians are not removing the device correctly which could be causing a more difficult removal and infections.More education on proper insertion and removal along with reviewing of the ifu's are indicated.
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Search Alerts/Recalls
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