Highlighted Reports
MedSun: Newsletter #60, May 2011

This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period February 1 through February 28, 2011. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.


ANESTHESIOLOGY

Device:
Type: Dry Suction Water Seal Drain
Manufacturer: Atrium Medical Corp
Brand: Oasis
Model#: 3600 Single Collection

Problem:
Chest tube at 20cm Suction at shift change. Assessed system a few times during the night and orange floating detection device was at the 20 cm mark. Nurse was sitting next to patient's bed and, two hours later, noted that the orange floating detection device was only half way into monitoring section indicating suction was not at 20 cm. The system was found to have self sealed off at the blue water seal outlet which is normally open. It actually looked like it had melted prior to puncture. Same nurse set this up the day prior and is 100% confident that it did not look abnormal. Same nurse replaced the Oasis CT [Chest Tube] device with a new one. While awaiting the arrival of drain, hole was made in connector to allow suction to occur.

Night lights were not only low, dim and cool but were far away from the device. Surrounding light should not be a contributing heat factor.


CARDIOVASCULAR

Device 1:
Type: Catheter, Transluminal, Coronary Angioplasty, Percutaneous
Manufacturer: Boston Scientific
Brand: Apex Monorail 3. 5x12
Lot #: 13967846
Other #: 38959-1235

Device 2:
Type: Wire, Guide, Catheter
Manufacturer: Boston Scientific
Brand: Bmw Guidewire
Other #: 190cm; .014/190 J"

Problem:
Balloon was inserted along guidewire but balloon was unable to advance over the wire. Physician feels that wire was defective, too thick to thread the balloon.
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Manufacturer response for cardiac cath balloon, Apex Monorail 3.5x12: They are investigating.
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Manufacturer response for guidewire, BMW 190cm guidewire: They are investigating.


GENERAL & PLASTIC SURGERY

Device:
Type: Clip Applier
Manufacturer: Ethicon Endo Surgery, Inc.
Brand: Ligamax
Model#: EL5ML
Lot #: G4UH51

Problem:
A young male was taken to surgery for symptoms of cholecystitis and biliary dyskinesia. The patient was in need of LapChole procedure. Upon the surgeon using the 5mm Ethicon Ligamax Endoscopic Clip applier it misfired and would not administer the clip needed for closure to the cystic duct. There was no injury to the patient and a new clip applier was obtained to finish the procedure. The original clip applier was taken out of service and sequestered for Risk Management pick up. Patient's procedure was completed and patient was taken to PACU for recovery.


Device:
Type: Clip Applier
Manufacturer: Ethicon
Brand: Ligamax 5mm Endoscopic Muliptle Clip Applier
Lot #: G4U68Y
Cat #: EL5ML

Problem:
As reported by the OR team, the surgeon encountered difficulties with the clip applier. The handle appeared to "jam" when attempting to fire the device to apply the clip and also at the point of releasing after the clip had been placed, causing the tissue in the operative cavity to tear. The surgeon has used this particular clip applier before without any reported issues.


GENERAL HOSPITAL

Device:
Type: Catheter, Picc
Manufacturer: Vygon
Brand: Lifecath SPicc (Sil)
Lot #: S 0882 & 10101
Cat #: 2296.211
Lollipop Icon

Problem:
PICC catheter used in NICU was noted to be leaking/breaking below the secure-ment hub. The PICC catheters appear to be leaking from the same site as the breakage.
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Manufacturer response for PICC Catheter 1.9 Fr 30 cm, Lifecath S PICC (SIL)
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Picked up remaining catheters for credit.

See device image:
Image shows point where PICC catheters were leaking.  Breakage noted below the secure-ment hub. The PICC catheters appear to be leaking from the same site as the breakage.



Device:
Type: Catheter, Picc
Manufacturer: MedComp
Lot #: MBBT440
Cat #: MR17013101

Problem:
PICC line tubing that attaches at the end of the hub component broke and began leaking profusely. Break in line is not visible to the naked eye. Patient was taken to the OR for PICC exchange procedure. Procedure was successful and patient had no complications related to the procedure.

PICC lead RN verified the leak by injecting fluid through the line after it had been removed.


Device:
Type: Catheter, Picc
Manufacturer: Becton Dickinson
Brand: Bd L-cath Picc Dual Lumen Catheter
Lot #: 0027376
Cat #: 384467

Problem:
Patient became agitated with tachycardia, hypertension, and fever. Later a leaking PICC line was discovered, which had allowed loss of sedation meds, possibly allowing patient to enter withdrawal. PICC line was replaced with single lumen catheter for remainder of therapy.

This model PICC line has been observed to leak several times within the past year. Staff believes catheter will often leak after two weeks of use, but this one developed a leak after only 24 hours.
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Manufacturer response for PICC catheter, BD L-Cath PICC Dual Lumen Catheter
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Manufacturer's representative affirmed that cause of repeated leaks has been identified as inadequate glue bond where tubing joins to molded bifurcation. Redesign is in progress.


Device:
Type: Crib, Infant
Manufacturer: Hard Manufacturing
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Problem:
Bottom securing latch spring and guide broke. Clinicians are concerned that with only 3 of 4 security points working. There is a risk of the infant becoming wedged between rail and mattress.


Device:
Type: Picc, Catheter
Manufacturer: Covidien
Brand: Argyle Picc
Cat #: 43303
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Problem:
A nurse taking care of a neonate noticed blood backing up in the PICC line. TPN (Total Parental Nutrition) was supposed to be infusing, but it was not going through the PICC. The nurse said on close inspection of the device, she noticed a leak at the adaptor portion of the PICC. The PICC was discontinued. The catheter was intact.


RADIOLOGY

Device:
Type: Computed Radiography, Pacs System
Manufacturer: Philips Medical Systems
Brand: Pcr Eleva

Problem:
In our Radiology Department, a software upgrade was performed on the Philips Computed Radiography (PCR) Eleva from version PCR 1.1.5 to PCR 1.2. This upgrade was performed, beginning in late fall of 2010. On the new 1.2 version there is a small symbol that transfers over to the PACS (Picture Archive and Communications Systems). Our concern with this feature is the icon can be mistaken for the marker denoting the patient's right (R) side. On certain radiographic views, we utilize AP-PA mirroring in conjunction with a hanging protocol. In the mirroring process the icon could be placed on the patient's left side but you see the R mirror icon. In our practice, the technologists place the appropriate laterality "L" or "R" marker on the correct side but on PACS there also is the mirror icon that could be on the left side of the patient. This is of concern to us as radiologists, surgeons, clinicians may not know this is an AP-PA mirror icon and may mistake the icon for the wrong side of the patient's body. As of January 2011 the affected features have been turned off and some systems reverted to prior software.

Detailed information has been provided to the manufacturer and they have indicated they are working to resolve the issue.


Device:
Type: Ct Scanner
Manufacturer: GE Medical Systems, LLC
Brand: Ge Light Speed Ultra
Model#: GE Light Speed Ultra
Other #: GE ID 415723SCT1

Problem:
Radiology/CT technician prescribed only the chest to be imaged graphically, however scanner continued to scan abdomen and pelvis. GE contacted to evaluate the scanner. GE could not reproduce the problem and cause of event being investigated by GE.
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Manufacturer response, according to reporter, for CT Scanner, GE Light Speed Ultra
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Unable to determine if scanning was from operator issue. Table movement errors observed, but unclear as to whether this was related to the event. Cradle encoder assembly ordered. GE will monitor logs to see if cradle assembly might be needed.


Device:
Type: Gemini Gxl 16
Manufacturer: Philips Healthcare (Cleveland)
Brand: Gemini Gxl
Model#: Gemini GXL 16

Problem:
Patient to outpatient imaging for PET/CT scan utilizing nuclear med Gemini GXL 16 slice machine. Patient was injected with 14.89 mCi of FDG (fluorodeoxyglucose). When attempted to proceed with scan the system "hung up" due to software application and the bed portion of the scanner would not move. Procedure cancelled, patient rescheduled. Philips was called and was able to connect remotely and "re-initialized VME rack, completed function testing" and was able to complete tests for rest of the day. Same patient returned 1 week later to complete original test and the same exact issue happened. Patient had already been injected with 16 mCi of fluorine 18 FDG and again the scanner would not proceed with collecting images. Clinical Engineering troubleshooting issues, have requested staff to run QC check and emulation prior to injecting patient to ascertain machine will perform as expected. Philips has technician on-site this week to trouble shoot issues should any arise. Unknown at this time if patient will be rescheduled again or whether diagnostic test will be performed at another facility.

Manufacturer response, according to reporter, for Gemini GXL 16, Gemini GXL: Staff called Philips who was able to troubleshoot issue and "unfreeze" scanner. Continue to work through issues as they arise.


Device:
Type: Mri Scanner
Manufacturer: GE
Brand: Ge Hd 12. 0
Model#: GE HD 12.0
Other #: 1.5T

Problem:
Anesthesia cart brought to room (cart designed for use in MRI) and drawer was opened. One of two Allen wrenches in the drawer flew out of the drawer in the direction of the magnet. There was an unnamed patient in the tube; however, there were no injuries. The devices were removed from the MRI suite.

We have all the standard precautions in place - anteroom, signs, staff education, and special nonferrous carts for anesthesia and other nonferrous items for MRI, and screening/checking processes before anyone brings anything in. Someone erroneously put the wrench in the cart. The final check process by the MRI staff failed in this instance, and the wrenches, which are NOT supposed to be in the cart, were not discovered before bringing in the cart.


Device:
Type: Ultrasound, Diagnostic, Bladder Scanner
Manufacturer: Verathon Incorporated

Problem:
The patient had orders to be discharged after she was able to pass her voiding trial. Throughout the day she had high post void residuals, although they were improving with subsequent voids. The patient was very frustrated that the PVR (post void residual) amounts were still not low enough (169mls) for discharge and did not want to go home with a foley catheter. I discussed the matter with the doctor and he said that she was voiding large quantities (800mls) and he said that she could go home if she agreed to void every hour and set an alarm to get up to void at midnight. When I returned to the patient room with the discharge paperwork she stated that she had voided another 100 mls and wanted me to scan her bladder again. At this point she should have less than 100 mls in her bladder because a few minutes before her PVR was 169. The patient stated that she felt like she had really emptied her bladder this time. I scanned her bladder again and the readings were between 270 and 360. The patient stated that if her residuals were really that high when she felt like she was empty, than it would be best to insert a foley catheter. I inserted a foley catheter into her bladder (with good visualization) and her bladder was completely empty. It is unlikely that a patient would have a PVR of 300 range after voiding 900 mls of urine and impossible that a bladder with 300 mls of urine would result in a cath amount of zero. I believe this problem was caused by equipment error.


Device(s):
Type: X-ray Machine, Portable
Manufacturer: Fujifilm Medical Systems USA, Inc.
Brand: Fcr Go
Model#: FCR-MD 101

Problem:
On two different FCR-MD 101 portable X-ray machines during reverse movements, the devices lunged backwards. Fuji was notified and Fuji installed EPROM Ver. 28 on both machines. About a month later the same problem occurred again on both machines and pinned the operator against the wall and caused bruising of the forearm. Clinical Engineering pulled machine and inspected the front casters. The front casters were found to be dirty and causing the wheels to have stiff motion.

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Special Note: The lollipop icon distinguishes highlighted reports that describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations. FDA defines pediatric patients as less than 21 years of age.


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