Model Number VMP306PX |
Device Problem
Leak/Splash (1354)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/13/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
One single dpt - vamp jr system with attached needless canula was returned for evaluation.Dry blood was visible at tubing to proximal stopcock bond joint of vamp jr system.The reported event of leakage from the connection was confirmed.Leakage was detected at bond joint between the pressure tubing and the proximal stopcock female luer.Red dye solution was manually injected to detect the leak path.Leakage occurred through a channel across bonding area.Tubing od, 0.1085", measured near bond area, was within specification.Mold cavity of the proximal stopcock was a13.No other visible damage was observed from the kit.Udi number for this device is (b)(4).Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Event Description
|
It was reported that while using this vamp jr., there was blood backing up in the tubing and there was leakage from the connection point on the transducer.There was no patient harm, however, there was 1ml of blood loss.The patient was an infant at (b)(6) gest age, (b)(6) grams, (b)(6) day old.There was no procedure being conducted, had just hung iv fluids.Nurse was at bedside at time and reported fluid loss was minimal.Baby did receive a transfusion after event.
|
|
Manufacturer Narrative
|
A device history record review was completed and documented that device met all specifications upon distribution.Even though there was blood backing up in the tube and that the blood loss was minimal from the transducer issue, it was confirmed with the customer, that the blood transfusion was not given because of the issue with the transducer kit.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Manufacturer Narrative
|
A capa was initiated to address this condition to make the solvent bonding process more efficient.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as a part of the monthly review.
|
|
Search Alerts/Recalls
|