Type: Endoscope, Accessories, Narrow Band Spectrum
Manufacturer: Olympus Medical Systems Corp.
Brand: Single Use Distal Cover
Model #: MAJ-2315
Other: Lot numbers higher than H2530
Event Description: During an endoscopic retrograde cholangiopancreatography (ERCP), the duodenoscope requires an Olympus distal cover (using the redesigned MAJ-2315 cover) be attached to the distal end of the insertion tube and around the forceps elevator. The cover was applied at the beginning of the case. When the case was finished, the patient was extubated, turned supine, and moved onto a cart. During the debrief timeout at the end of the case, we discovered the distal ERCP cover was not on the scope. We asked the doctor; he didn’t remove the cover. We found it in the patient's mouth and removed it without difficulty. This is the second time recently that a distal cover detachment occurred. Covers are being put on correctly, following the manufacturer's Instructions for Use, at the beginning of the procedure. The team uses the covers correctly, but upon device removal, the cover bumps past the bite block, causing the cover to pop off. We have added a new step in our process to check the tip of the scope immediately after removal of the device from the patient because this is such a concern for us. We have been using the second-generation distal cover. When checking our inventory, we had Lot# H2624 x 40 each and Lot # H2714 x 16 each. We had located only one of the recalled lots (MAJ-2315 Lot # H2126), which was pulled from use and destroyed. Our Endoscopy Account Manager has been apprised of this event and concern regarding covers dislodging. They asked to schedule an in-service to ensure the distal cover is being placed correctly on the scope and sent the user guide for reference.
Type: Stimulator, Spinal-cord, Totally Implanted for Pain Relief
Device 1:
Manufacturer: Boston Scientific Neuromodulation Corp.
Brand: WaveWriter Alpha SCS System
Model #: SC-1232
Devices 2 & 3:
Brand: Infinion CX
Model #: SC-2317-70 (x2)
Device 4:
Brand: Click X
Model #: SC-4318
Cat #: SC-4318
Event Description: The patient (pt) has spinal cord stimulator and had an MRI. Several days later, the pt complained of a burning sensation on the back. Pt examined in clinic and suspected 1st degree burn noted near battery pack. Pt treated with antibiotic ointment and silver sulfadiazine. A double check of MRI safety precautions and interrogation of device completed; no breech in protocol noted.
Type: Pump, infusion
Manufacturer: Carefusion 303, Inc.
Brand: Alaris
Model #: 8015
Event Description: It has been discovered that impurities are seeping into the two-piece handle on the Alaris PCU 8015 device. Several pump handles have been opened to reveal what appears to be remnants of food, blood, and mold. This is a huge infection control risk.
Photos show examples of what was found when the handle of the Alaris IV Pump was opened. Along the edges and inside the device is visible evidence of dried, discolored substances and soil, including obvious fluid ingress.
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Type: Dialyzer, High Permeability with or without Sealed Dialysate System
Manufacturer: Baxter Healthcare Corp.
Brand: Prismax System
Model #: 955626
Cat #: 955626
Event Description: This is a summary of multiple reports. Since May of last year, over twenty separate incidents have occurred involving eleven different Baxter PrisMax Continuous Renal Replacement Therapy (CRRT) Systems (all REF: 955626) causing considerable blood loss to patients, delays in CRRT treatments, and risk of air embolization due to clotting and air present in filters and access lines. In some cases, patients required additional treatment including administration of units of packed red blood cells to achieve normal hemodynamic parameters. During every incident except for one, blood could not be returned to the patient in need of uninterrupted CRRT. Some of the recurrent failure modes include air or clotting present on access lines, clotted filters, high filter pressures, extreme negative access pressures, unexpected shutdown of PrisMax systems without warning, loss of pre-programmed settings, excessive foaming within deaeration chamber, air and bubbles within deaeration chamber, and failure to capture air in lines. The User Facility has been working closely with Baxter including multiple site visits for over two and a half years to identify the problems and fix them.
This is an example of one incident: The Baxter PrisMax CRRT System was running without any issues when suddenly negative access pressure alarm was noticed. This RN inspected patient's hemodialysis (HD) line and noticed lots of air present in the red access line. Patient was sedated and not moving. Patient's blood pressure suddenly dropped to 70 systolic with mean arterial pressures in the 40s, pressor requirement increased at that time. Access to patient automatically clamped. RN was unable to return blood to patient due to air/clotting present. Blood also noticed to be backflowing into the dialysate bags. Team Lead notified and machine taken by for further inspection. Patient ended up losing that filter of blood and needed a unit of packed red blood cells. Patient returned to normal hemodynamics within 10 minutes.
Type: Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Manufacturer: Bard Access Systems, Inc.
Brand: PowerPICC Provena
Model #: S1275108FD5
Lot #: REGZ0135, REHN2437 (x2), REGY0409, REGY0842, REGW1593, REGY0842, REGZ0989
Cat #: S1275108FD5
Event Description: This facility had nine events with seven different lots, all with the same problem. Each were reported to FDA MedSun and the Manufacturer. Our User Facility’s System Vascular Access Leadership contacted Bard about the issue and were told by Bard this is the first time they (Bard) have been made aware of any leaking related issues. Multiple devices have been leaking during flushing. Additionally, two kits noted leakage at the rubber-like stopper and stylet before insertion and were replaced. A third only leaked after insertion and resolved with stylet removal. The PICC line was successfully placed. Each time the stopper falls off during flushing, which is one of the final steps of PICC placement, the staff must remove everything and start back at the beginning with reinsertion. This is very painful for patients and stressful for both patients and staff. Additionally, the User Facility is extremely concerned about infection risks.
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