Highlighted Reports
MedSun: Newsletter #33, February 2009

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 November 1 through November 30. 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.


Device: tubing, IV
Manufacturer: Hospira Global Medical Affairs
Brand: LifeShield latex free extension set, 8 inch
Lot #: 6614ons
Cat #: 19197-01

A patient was to undergo a CT chest- PE (pulmonary embolism) exam. The IV extension was connected to an 18 gauge angio. Upon introduction of contrast via injector, the tubing split open from internal pressure. A repeat attempt had a similar result.

Comment from FDA: Please see article, which addresses issues like this one, featured in this month's articles section. Online available: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=33#2

Device 1: medication administration system
Manufacturer: Cerner Bridge Medical Medpoint

Device 2: bar code scanner
Manufacturer: Honeywell, Metrologic Division
Brand: BT Focus Scanner with 9535 Cradle

During a medication pass, the bar code scanner failed and the nurse was unable to scan the patient's ID/medication. The device failed and there was not enough time to troubleshoot or reset the device. The medication had to be given STAT and the error occurred when the scanner failed and the RN wasn't able to verify that the wrong dose was being given to the patient.

Device: Pump, IV
Manufacturer: Hospira Global Medical Affairs
Brand: Symbiq Pump

Staff is to use caution when entering the patient's weight in the Symbiq pump system. Recently, two wrong doses of heparin errors were reported because the patient's weight was entered into the Symbiq in pounds and not kilograms. These pumps were set to deliver almost twice the correct dose. Staff was made aware that there is no feature on the Symbiq pump that helps with the entry of weight. Currently, the system only provides alerts around limits based on the dose of units/kg/hr. For example, the pump is set up with a soft limit of 20 units/kg/hr. If a nurse tries to enter 21, they will get an alert to verify that this is the actual dose they want. Company representatives have been contacted and they report that a newer version of the software being developed may help with this. In the meantime, we are relying on the nurse to enter the correct weight.

Device: pump, infusion
Manufacturer: Hospira Global Medical Affairs

An infusion was started. Eleven minutes later, the pump alarmed with malfunction S321, Code: pump bolus overshoot, Alarm ID: 109, Generic Arg1:109, Arg2-4:0. The alarm was acknowledged and the pump had to be shut off. The infusion was re-started on a different pump. Please note that this exact pump had previously been involved in a patient incident (a report was submitted through Medsun at that time), and had been factory updated to the latest configuration to prevent this issue. We have seen over 10% of our new Symbiq pumps malfunction while infusing medications to patients.
Manufacturer response for infusion pump, Symbiq
They are aware of the malfunctions S321 + S421 (error codes). Other hospitals have seen the same issue but to a lesser degree. They continue to investigate and work towards a sustainable corrective action.

Device 1: Pump, IV, CPU,
Manufacturer: Cardinal Health
Brand: PCU model 8000
Model #: 8000
Other #: 4071545

Device 2: Pump, IV, module,
Manufacturer: Cardinal Health
Brand: Alaris 8100
Model #: 8100

Device 3: Pump, Syringe, module
Manufacturer: Cardinal Health

Infant in NICU developed acute deterioration in respiratory status, requiring increased oxygen and ventilator support. It became apparent that the infant was over-infused with D13 Total Parenteral Nutrition (TPN) through an Alaris Large Volume Pump (LVP) connected to a Point of Care Unit (PCU). The Alaris Infusion Pump involved was accidentally programmed for 68 mL/hr instead of the ordered rate of 6.8 mL/hr. The pump infused for approximately 2 hours, infusing approximately 150mL of fluid during that time. The infant became extremely hyperglycemic and hyperkalemic, and continued to deteriorate despite aggressive medical and ventilatory management. The patient expired the next day. It is believed that, although the pump did not malfunction, inherent design flaws in the infusion pump may have contributed to this event.

1. PCU Model #8000
2. Large Volume Pump (LVP) Model #8100
3. Syringe Module (attached, but not directly involved in incident)

Root Cause Analysis:
1. Preventative Maintenance was up to date at the time of the incident

2. Preventative Maintenance was performed after the incident and no issues were found

3. The historical data logs of the pump were downloaded and reviewed. It was verified that at the pump was programmed for a "basic infusion" at 68 mL/hr and a Volume To Be Infused (VTBI) of 150mL. The pump ran from approximately 2 hours, with a 2 minute pause. The total contents left in the IV bag of D13 TPN was 75mL, measured using a graduated cylinder. The bag was originally filled with 238.2 mL, therefore approximately 163 mL were infused in total.

4. Mechanical testing was performed to determine the force required to press the buttons on the pump. Particular interest was paid to whether or not the force required to press the decimal point was higher than the force to press the other number digits. It was found in preliminary testing that the force to press the decimal point was greater than the force to press the "6" or the "8" buttons. An RN programming the pump could potentially press the "6" then the decimal point, but not have it register on the pump because not enough force was exerted due to human factors design issues.

5. The Alaris pumps do not make a "beeping" noise as the buttons are pressed for this patient population modality. Therefore, there is no audible confirmation to the RN programming the pump that he/she has pressed a button and that it has registered.

6. It is being investigated what level of visual acuity is required to read the pump with varying lighting levels and heights of the pump.

Device: bed, ac-powered adjustable hospital,
Manufacturer: Hill-Rom Company, Inc.
Brand: Total Care Bed

Upon entering patient's room, nurse found patient out of bed, laying next to bed on the floor. The bed exit alarm was in use, with the alarm delay set at 2 seconds. Upon entering the room, nurse found that the sound of the alarm was at a volume level that was lower than normal functioning. In addition, the sound of the alarm was a different sound than that associated with normal functioning. At a point outside of the patient's room where the alarm sound would normally have been heard, the alarm sound was not audible.
Manufacturer response for Patient Bed, Total Care Bed
Hill Rom technician looked at alarm. Stated "tested bed alarm. Initial sound was not the usual sound of the alarm. It was a softer sound, almost a vibration. This lasted for 3 seconds or so, then the sound became louder." Ordered repair on bed alarm.

Device: Drug / supply dispensing system
Manufacturer: Omnicell, Inc.
Model #: OSCT; Computer for Medical Storage Cabinet

Nurse approached Omnicell on north side of unit, just after 12 midnight - she entered her user ID which Omnicell message stated was "invalid". Then, as she reached or possibly touched the "OK" button on screen with her right index finger, she felt a "huge shock" go through her right thumb, up her arm and to her back. Her thumb was reddened, as if burned. The Omnicell went dark, and the nurse went to the Emergency Room for evaluation. She also went to Employee Health Service in the morning. She went home and was taken off work secondary to "back spasms". She was off one night, and called in the next night due to pain/back spasms. She is still off, and seeing Employee Health Service today for follow-ups.

Biomed was called. They instructed clinicians to call maintenance-electrician. Electrician came up to assess plugs, etc. in the morning, and thought "static electricity" caused the shock. Biomed called again, and clinical engineer came up in the afternoon to evaluate.

Company came in later in the morning and replaced the "omni box". The Omnicell was placed back on line. Biomed to follow up to evaluate this with the company.


Device: Emulsification, Phacofragmentation
Manufacturer: Alcon Laboratories, Inc.
Brand: Infiniti
Model #: Infiniti Anterior Vitrectomy Vision System

Emulsification of the nucleus was begun with the phaco tip in the sculpt mode, and it was observed during the first 2 passes through the lens material that the white debris did not clear rapidly. This took approximately 10 seconds of phaco time. The handpiece was immediately removed from the eye. As it was removed from the eye, it was observed that the incision area had turned somewhat white, and there was a gaping of the incision area, suggesting there was a mild incisional burn from the phacoemulsification handpiece overheating. The handpiece was then tested and felt to be working appropriately outside of the eye. The aspiration and flow were working appropriately. It was reinserted in the eye, and it was begun in use and appeared to be functioning properly. The remainder of the emulsification was nearly completed, until removing the last quadrant of the nucleus it was observed that the capsule suddenly broke and this fragment fell back into the vitreous and vitreous prolapsed forward. The phacoemulsification was discontinued. An anterior vitrectomy was then performed until the vitreous was removed from the anterior chamber.

Manufacturer response for Emulsification, Phaco, Infinity
sounds like user error


Device 1: Prosthesis, Total Hip Arthroplasty, Femoral Head
Manufacturer: Wright Medical Technology, Inc.
Brand: BFH

Device 2: Prosthesis, Total Hip Arthroplasty, Modular Neck
Manufacturer: Wright Medical Technology, Inc.
Brand: Profemur Z

The modular neck of the prosthesis fractured. When the fracture occurred the patient was walking and he reported that he fell. From the ED note it does not appear that any significant injury happened in the fall. Surgical intervention was necessary to return the patient to function.

Manufacturer response for BFH, Prosthesis, Total Hip Arthroplasty, Femoral Head
The fracture rate of these modular necks is around 0.013%, The company would be most interested in testing this implant to determine the mode of failure and whether some other action is necessary. The testing would be destructive testing.

Manufacturer response for Profemur Z,Prosthesis, Total Hip Arthroplasty, Modular Neck
The fracture rate of these modular necks is around 0.013%, The company would be most interested in testing this implant to determine the mode of failure and whether some other action is necessary. The testing would be destructive testing.

FDA Comment: age of device at time of event was 2 years old.


Device: Stylet, Intubation,
Manufacturer: Shore Medical, Inc.
Brand: Safety Stylette
Model #: S5000
Lot #: 3236
Cat #: PN:40200

Pre-term infant was delivered with NICU team at bedside. Infant immediately resuscitated. Intubation difficult given baby's size requiring multiple attempts. CPR initiated. Achieved intubation with 2.5 endotracheal tube (ETT) with appropriately sized Shore Medical stylette. Once the ETT was placed the stylette was unable to be advanced out of the ETT, and the blue coating over the wire began to shear off in the ETT tube. After multiple attempts were made to remove the stylette the entire ETT was removed from the patient's airway.

Device 1: Connector, Tubing
Manufacturer: Ohio Medical, Inc.
Model: Ohio Diamond N20 Connector

Device 2: Chemetron Model 500 Wall Outlet

We discovered a problem for hospitals using wall provided N2O and CO2 gas. We are able to plug the N2O Ohio diamond connector into the Chemtron Model 500 N20 outlet, which it is intended for, but also into the CO2 outlet, which it is not intended for. The Ohio diamond connector for CO2 does not fit in any other gas outlet. The outlets are designed to accept either a Chemtron or Ohio diamond connector. Labeling the connectors will not help, as the problem can still occur if the connector is turned over and inserted into the wall outlet. We plan to change the N2O connector from Ohio diamond to Chemtron on all anesthesia machines. The Chemtron fitting for N2O can not fit into the CO2 wall outlet.
Manufacturer response for N2O and CO2 connectors, (brand not provided)
Hospital contacted both Ohio Medical and Allied Health Care to alert them of problem.


Device: Crutches
Manufacturer: Cardinal Health
Brand: Adult Bush-Button Aluminum Crutches
Cat #: 742600010LF

Patient came to Emergency Dept for a fractured right toe which was reduced. Patient was discharged with crutches. In under two hours the tubing cut through the rubber tip and the patient slipped and fell. The patient was not harmed. When the crutch was examined by the patient's mother, it was noted that the crutch did not have a washer at the end of the aluminum tubing like the other one had. The Emergency Dept was notified. The crutches in the department was checked and no other crutch had this defect.


Device: Dermatome, Skin Mesher
Manufacturer: Aesculap
Cat #: Size 1:6

The new Aesculap skin mesher was used. Nurse opened up the carrier. The wrong size was opened. Doctor said that with the old dermatome carriers, it was easy to see which size to use. With the new carriers, it is harder to tell what size you open. The rep should have educated the nurses on this, per doctor. Scrub nurse in and said that she was in-serviced and had used the new Aesculap skin mesher twice and never was informed of the difference in packaging.

Harvest skin was meshed too large and could not be used. A 5 x 8 centimeter piece of skin could not be used and had to be discarded. The correct skin carrier was obtained from office. A second skin harvest was done successfully. The patient's donor site was bandaged and the surgery continued.

OR Rep states that the mesher carriers determine the skin size and the sizes on the package are very small and do not stand out very well (need larger, bolder writing, different colors for different sizes-something!). The size is also on the carrier itself so Doctor should have seen/checked the size when he used it.

Device: Mesh, Surgical Hernia
Manufacturer: Davol, Inc. Sub. C.R. Bard, Inc.
Brand: Bard Composix Kugel Mesh Patch
Lot #: 43APD292
Cat #: 0010207

Patient had partial small-bowel obstruction secondary to adhesions that caused multiple hospitalizations. Required surgery. At time of surgery, during dissection of the adhesions to the anterior abdominal wall, the left lateral inferior portion of the prosthesis was found to have a fracture of the supporting ring at its periphery. The prosthesis was adherent to loops of small bowel.

Device: implantable biopsy marker,
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: MammoMARK 2
Model #: MRM4008
Lot #: E4L21J


Stereotactic core breast biopsy performed for calcifications in the left central breast. Metallic marker clip was deployed by radiologist. When removing the clip deployment device, a small portion of the plastic distal catheter tip was sheared (ripped off). Prior to clip placement, the device was intact. Post procedure mammogram was obtained which did not definitely demonstrate the plastic tip. All trash, needle biopsy, gauze, drapes and all material related to the procedure were searched by the technologist, radiologist, and supervisor. No tip fragment found and Ethicon representative notified.


Device: electrodes, ECG, monitoring,
Manufacturer: Covidien Kendall
Brand: MEDI-TRACE 535 Foam Electrodes
Cat #: 31115788

Patient needed urgent cardiac monitoring. Leads applied by RN. No reading obtained; Defibrillator/monitor had been checked and was functional earlier in the shift. During troubleshooting, it was noted that one of the electrode pads had no gel in it-it was new out of the package.

Device: pacemaker extension,
Manufacturer: Remington Medical, Inc.
Brand: Disposable Screw-down Extension Cable for pacemakers
Cat #: FL-601-97

Attempting to attach patient pacing wires to disposable pacing cable during code. Reportedly staff unable to secure pacing wires into cable end. Tried 5 cables before successful attachment.

Manufacturer response for Disposable extension cable for pacemakers:
[A] MFR is aware that the clearance for the pins our facility is inserting into their connector is only .004 inch. Given this tight tolerance, their connector has to be unscrewed to its maximum to accept this pin.
[B] MFR understands most clinical users insert a Keith needle directly into the connector, versus the pins our facility is using.
[C] MFR states the Keith needle tends towards the minimum diameter for their connector, & the pins our facility uses tend towards the maximum. MFR feels a change either way in the connector would prevent someone from being able to use their product, whereas both currently work.


Device: Imaging Table
Manufacturer: Stille Surgical
Brand: ImagiQ
Model #: ImagiQ


Doctor finishing a left femoral popliteal bypass, stapling leg, when the foot of the table started drifting down. The table was leveled and a stool was placed under the leg to finish the procedure. Patient was unharmed and unit was sent to Biomedical Services. Examination of table found that a hydraulic hose feeding the trend/reverse trend cylinder has been damaged from rubbing against the support blade used to support the hoses feeding the upper portion of the table. The table is being held for inspection by manufacturer.

Device: X-ray system, C-arm, portable,
Manufacturer: GE OEC Medical Systems, Inc
Brand: OEC 9900 Elite
Model #: OEC 9900 Elite

The C-Arm unit's hard drive malfunctioned during the procedure, resulting in a loss of images. Based on the manufacturer's field service report, the system initially displayed intermittent error messages regarding the charging system and its batteries, which were then replaced. A second service call (shortly afterwards) indicated that the WS IDE (workstation integrated drive electronics) was found corrupted due to improper shutdown issues caused by the ISD, PCB (printed circuit board), and UPS (Uninterruptible Power Supply), all of which were defective. All were replaced, and adequate operation of the system with the new parts, was verified.

Additional Information:

Power Injection of MRI and CT Contrast Media. FDA MedSun Website. February 2009.

MedSun Newsletters are available at www.fda.gov/cdrh/medsun