ST. JUDE MEDICAL, INC. COOL POINT¿ IRRIGATION PUMP TUBING SET; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Air Embolism (1697)
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Event Date 02/08/2023 |
Event Type
Injury
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Event Description
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During the procedure, when changing the saline bag, air was introduced into the irrigation tubing by hospital staff.It was verified with the physician multiple times, that the tubing was off to the patient.The staff felt the tubing was not flushing correctly, and it was confirmed that it was not off to the patient and air was flushed into the left atrium.Elevated st was noted immediately, but within 5 minutes it resolved back to normal.The patient had motor control after intubation and all other stats seemed normal as they left the room.
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Manufacturer Narrative
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Additional information: g3, h2, h3 h6 code: caused traced to user: d11, failure to follow instructions d1101 the results of the investigation are inconclusive since the device was not returned for analysis.However, information from the field stated that ¿air was introduced into the irrigation tubing by hospital staff¿ and ¿it was confirmed that it was not off to the patient and air was flushed into the left atrium¿.The cool point pump operator manual states ¿do not prime the catheter while it is in the patient¿.Based on the information received, the cause of the reported issue is consistent with the incorrect use of the device.
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Search Alerts/Recalls
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