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The reports that follow represent a cross section of device related events sent by MedSun Representatives during the prior month. The reports are presented as submitted by MedSun Representatives and in some instances, have been summarized and edited for clarity.
Type: Cannula, manipulator/injector, uterine
Manufacturer: Catheter Research, Inc. (Thomas Medical)
Brand: K-UMI manipulator | Model: TMI6003 | Cat: TMI6003
Event: The physician found part of the manipulator (balloon portion) in the patient's vagina during an office visit. Patient underwent surgery with left partial removal of the fallopian tube over one month prior. The manipulator was inserted into the uterine cavity for manipulation of the uterus. The surgeon disclosed the retained object to the patient, started the patient on an antibiotic, and will return the retained item back to the hospital.
Type: Catheter, steerable
Manufacturer: Boston Scientific Corp. | Brand: Faradrive | Model: M004PF21M402
UDI-DI: 10846835004434 | Lot: CL12882 | Cat: M004PF21M402
Event: A sheath was inserted, and an error message read "faulty air valve." The sheath was removed and replaced with a working sheath. No harm to patient.
Type: Marker, radiographic, implantable
Manufacturer: Hologic, Inc. | Brand: BioZorb | Model: F0405
UDI-DI: 15420045514065 | Lot: F1-171005 | Cat: F0405
Event: This facility has had multiple patients experience problems with this device.
Patient 1 had a partial mastectomy (breast removal) with a BioZorb placement. Nine days post-op, the patient developed warmth, swelling, redness, pain, and fever. The patient was treated with oral antibiotics and had a drain placed (BioZorb 4x5 cm).
Patient 2 had a partial mastectomy, removal of a lymph node, and placement of a BioZorb. The following month, the patient had a second tissue removal operation, repositioning of the initial BioZorb, and placement of a second BioZorb. Approximately 18 months after the original procedure, the breast was swollen with firmness and nipple inversion (two BioZorbs 2x3 cm).
Patient 3 had a partial mastectomy with a BioZorb placement. The BioZorb was noticeable post-op the same month as the surgery through 10 months after surgery. Eleven months after the original surgery, the patient had tissue removed for examination. An examination of the tissue could not be performed due to the BioZorb 3x3 cm.
Patient 4 had a right partial mastectomy with node tissue examination and BioZorb placement. Almost three years later, the patient felt a noticeable, hard lump near the BioZorb site. On [date redacted], the patient had removal of lesions in the right breast. The surgeon notes state, "Several clips were found in the cavity from the BioZorb that had dissolved" (BioZorb 2x3 cm).
Patient 5 had a partial mastectomy, lymph node tissue removal, and a BioZorb placement. Approximately two months later, the patient had a superficial wound identified as the BioZorb sticking out from the skin. The patient returned to surgery. The surgeon noted the BioZorb had begun to break down into two pieces. Both pieces were removed from the patient and discarded (BioZorb 2x1 cm).
Patient 6 had a partial mastectomy and two BioZorbs placed. The patient stated on post-op day one the breast was warm and red. The following month, the patient had an irrigation, removal of dead skin and tissue, and received oral antibiotics. The patient’s complaints of breast swelling and drainage lead to the removal of the BioZorb (BioZorb 3x4 cm and 3x3 cm).
Patient 7 had a partial mastectomy, removal of lymph nodes, and placement of a BioZorb. Nine days post-op, the patient had skin loss along the edge of the surgical cut that drained 75 ml. Six months after the original surgery, the breast wound drained yellow cloudy fluid. The BioZorb was easily felt. The patient required antibiotics, several fluid removals, and removal of the BioZorb. The BioZorb was removed in two pieces and discarded (BioZorb 4x5 cm).
Patient 8 had a partial mastectomy, lymph node examination, and a BioZorb placement at an outside hospital. Approximately two years later, the patient was seen by a surgeon for breast pain and yellow pus drainage. On [redacted], the patient underwent removal of dead skin and tissue and removal of the BioZorb. The BioZorb rejection caused a fistula (abnormal connection).
Device 1 Type: Humidifier, respiratory gas, (direct patient interface)
Manufacturer: Fisher & Paykel Healthcare LTD | Brand: MR850 Heated Humidifier
Model: MR850 | Cat: MR850
Device 2 Type: Nebulizer (direct patient interface)
Manufacturer: Aerogen LTD | Brand: Aeroneb Professional Nebulizer System
Model: Aeronebprox | Ref: Aeronebprox
Device 3 Type: Mixer, breathing gases, anesthesia inhalation
Manufacturer: Vyaire Medical, Inc. | Brand: Bird | Model: 03800A
UDI-DI: 10190752174634 | Ref: 03800A
Event: At approximately 11:40 am, the patient’s family yelled there was a fire in the room. Two members of the nursing staff immediately ran into the room to see fire at the patient’s head and the back of the patient bed appeared to be on fire. The staff assisted the family and patient out of the room. Three fire extinguishers were used but did not reduce the fire. Staff turned off the room’s oxygen supply, and an additional fire extinguisher was used to put out the flames. The fire was extinguished at approximately 11:47 am. The patient was being treated with high flow oxygen, which was coming from the wall supply, passing through a O2-air proportioner on an IV pole, mounted humidifier, and connected to the patient by nasal tube.
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