Highlighted Reports
MedSun: Newsletter #38, July 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 April 1 through April 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.



Type: Nephrostomy catheter 8.5 F 38 25cm 6SH
Manufacturer: Cook Medical Inc
Brand: Catheter Drainage Ultrathane MP Mac.Loc RB
Lot #: 2260385

This patient has had nephrostomy tubes placed and replaced beginning the early part of this year. Recently the tube was being replaced as it was nonfunctioning. The string fixation mechanism of the existing catheter was unlocked, but did not release. Attempts at advancing a wire through the catheter were unsuccessful. The catheter was then cut in an attempt to release the locking mechanism. Sheaths were advanced over the tubing; however none of these attempts were successful at removing the catheter. The catheter could not be removed and was clamped. It will likely need to be removed surgically.


Type: Enteral Feeding Container
Manufacturer: Abbott Nutrition
Brand: Ross Ready-to-hang Enteral Feeding Container
Model #: 00668
Cat #: 31321 FAN 8092

We are considering purchasing a new product for our facility-the Ross ready-to-hang enteral feeding container. During the evaluation process, we noted the potential for tubing misconnection and brought it to the attention of the rep. Although the feeding system has a "no IV" label, it is easy to take IV tubing and connect it to the system. If such an event were to occur, a patient who receives enteral feeding intravenously could have a fatal outcome. The following recommendations were made to the manufacturer representative:

1. Significantly increase the diameter of the opening where the feeding is spiked so that if an IV tubing was attempted to be inserted, it would not stay in place. This will require that the Ross patrol pump feeding tube set be modified so that the diameter of the piercing pin is increased to match the opening in the feeding solution container.

2. Tint the spike cap purple to provide a visual cue that the purple feeding tube should connect with the purple tinted cap. Currently, the cap is clear, just as the IV tubing is. (Enteral feeding tubing currently has an orange piercing pin. The company is changing to purple. Having like colors could be helpful in preventing a potential misconnection.)
Members from Risk Management and the Product Committee met with Abbott Nutrition Representative to present the information contained in this report and demonstrate how easy it was to connect the feeding to an IV set. According to the Abbott representative, there have been no reports of such a tubing misconnection to the manufacturer. The recommendations for changes were presented for the representative to take back to the Abbott quality department.

Type: Endoscopy Pump Tubing/cap Set
Manufacturer: Byrne Medical
Model #: EIP2
Lot #: ST2008-584
Cat #: 7911-4001

Staff report that they have been opening packages of endoscopy pump tubing to find that the tubing is cracked and broken upon visual inspection and prior to any use. Specifically, staff report that the tubing is not connected to the cap as it should be. Staff has returned four tubing sets from another lot and is now seeing the same problem in a different lot. The rep has been contacted directly by the endoscopy unit staff and informed of this problem. The product is stored in a cabinet on the endoscopy unit. The product remains in its original box until it is needed for a case. This is the only product stored in that cabinet. To our staff's knowledge, the product comes from the manufacturer via the manufacturer's distributor. When it arrives at the hospital, it comes through our receiving dock and then goes directly to Endoscopy.

Since this event occurred the Endoscopy staff has been in communication with the sales rep. The rep told the staff that the manufacturer has had several facilities complaining of the same findings-cracked tubing upon opening the packaging. The manufacturer believes that the cracks are related directly to the way that the device is packaged in that the tubing is wound too tightly. I have not received any feedback from the manufacturer as of yet.

Device 1:

Type: Light Source, Xenon
Manufacturer: Sunoptics Surgical
Brand: Titan400hp
Model #: S400T

Device 2:

Type: Light Source Headlight
Manufacturer: Luxtec, A division of LXU Healthcare, Inc.
Brand: Ultralight
Lot #: 155Q[?]
Cat #: 00-2900-9

During surgical procedure Surgeon wearing 400W Xenon headlight assembly noted left buttock with first to second degree burn from headlight. Headlight source turned off and burn treated and monitored. Final result was severe circular 2nd degree burn to left buttock approx. 6.0cm in diameter with the brightest center section at 2.5cm diameter. Surgery completed with no additional events.

Heat output test was performed. Set up and tested light output and beam diameter at three different lengths. Head light focus and dimmer tested OK. Light source lamp hours 117.9 OK. Estimated 10% damage to fibre optic strands.

Tested for temperature at following distances:
-3 cm distance with 2cm beam diameter: Temp = 120degreeC in 15 seconds
-15 cm distance with 5.0 beam diameter: Temp = 80degreeC in 3 mins
-60 cm distance with 12.5 beam diameter: Temp = 38degreeC in 45 mins.

No additional tests performed. Unit sent to manufacturer for evaluation.


Type: Tube, Feeding
Manufacturer: Covidien Kendall
Brand: Argyle Salem Sump Tube
Ref #: 7771410
Nasogastric (NG) tube placed for nutritional support after failing modified barium swallow in pt. status post stroke. Tube feeding started in the evening with stable vitals. No further vitals until approximately six hours later when patient was having tachypnea and low oxygen saturations. Tube feeds were stopped and portable chest x-ray done. It was missed that the NG was placed in the right lung lobe, but the patient was given respiratory support as per his code status, diuresised, and had tube feeds kept off. Pt. eventually made comfort care per the family and expired. Post mortem exam found the NG tube in the patient's right lung lobe.



Type: 27g Needle
Manufacturer: Eagle Labs
Brand: Anterior Chamber Irrigator Bend To Tip
Model #: 27ga Irrigation Anterior Chamber Needle
Lot #: P 5527
Cat #: 110-27-4WS
Eye surgeon used a 1cc syringe with BSS to hydrate the corneal incision after a cataract procedure. The cannula on the end of the syringe came off under pressure and struck the 6 o'clock iris root. There was bleeding within the eyes. Patient returned to hospital one week later without improvement of condition. Patient was admitted for oral therapy to promote clotting. The patient was hospitalized for one week, and was seen by a retinal specialist, who reported that there was no retinal detachment, but because of the patient's low pressure, he remained suspicious that the patient might have a cyclodialysis cleft.



Type: Permanent Sterilization System
Manufacturer: Conceptus, Inc.
Brand: Essure System
Lot #: 628434
Other #: Contraceptive Tubal Occlusion Device and Delivery System

The patient's initial procedure was performed several months ago. During this procedure, prior to attempted placement of the Essure device, a 2cm endometrial fibroid was detached via cautery; however was very difficult to remove. Several attempts were made to remove the fibroid without success and the decision was made to leave it in situ. Essure placement was then attempted. Difficult visualization was reported on the right side as the tubal ostium was somewhat occluded by endometrial tissue and on the left side, it was occluded by area of dissection of the previous fibroid. The patient returned to surgery 3 days later for abdominal pain. During diagnostic laparoscopy, the ESSURE spring was identified partially imbedded in the patient's bowel. The physician successfully removed the spring and the patient tolerated the procedure well.


Type: Birth Control Device, Permanent
Manufacturer: Conceptus, Incorporated
Brand: Essure
Cat #: ESS305

During sterilization procedure, physician fired the Essure Permanent Birth Control device, and did not see the coils come out as usual. The coils were not in the Essure Permanent Birth Control device when it was removed. Coils were not found in patient.



Type: Lead, Pacemaker
Manufacturer: Boston Scientific Cardiovascular Division
Brand: Fineline II Sterox EZ
Model #: 4469

The patient has a complicated surgical history including mechanical MVR. She underwent permanent pacemaker implantation for sick sinus syndrome 2 years ago. She was found on routine interrogation this month to have a non-functioning atrial lead with high lead impedance (which appeared to have started 7 months ago). She has preserved LV EF. She presented for atrial lead revision. At the start of the case, fluoroscopy revealed a complete break in the chronic RA lead 2 cm distal to the subclavian insertion site. A new RA lead (MDT 4076) was inserted. Decision was made NOT to attempt to remove the chronic RA lead due to 1) high risk of back bleeding given high R sided pressures and wide open tricuspid regurgitation with anticoagulation, 2) high risk of pocket bleeding due to adherence of the lead to the pocket, 3) risk of destabilizing the lead with risk of complete lead retraction into the brachiocephalic vein/heart. Although lead fractures are known to occur with pacing leads over time, this case was worth noting because of 1) the severity of the break (total clean break with 0.5 cm disconnection between two ends) 2) the location of the break (not subclavian but rather in the pocket) and 3) the relatively short period of time the lead had been in the patient (< 2 years). Hence it is unclear if there is a lead design issue.

Manufacturer response for Pacemaker lead, Guidant 4469
Technical services was contacted and will give reply regarding issue.


Type: Lead, Pacemaker
Manufacturer: Medtronic Inc.
Brand: CapSureFix Novus
Lot #: PJN1804955
Model #: 5076-52CM

As ventricular lead was being placed, it became immobile and unable to move forward. Apparent scar tissue under the clavicle and outside the subclavian. Decision was made to remove the lead. After extracted it was noticed that the tip was no longer visible. Under fluoroscopy it was visualized to be outside the subclavian vein and adjacent to the clavicle. Decision was made by physician to leave it there and a new sheath and lead were advanced.


Type: Oxygenator, Cardiopulmonary/ECMO
Manufacturer: Maquet, Inc.
Brand: Jostra Quadrox D
Model #: Jostra Quadrox D
Lot #: 70003778
Cat #: Hmod 2030

Crack in the polycarbonate housing of the oxygenator was noted. In the course of 24 hours the crack had gotten larger. It was replaced in a controlled manner per standard protocol. No adverse effects noted.


Type: Physiological Monitor Module
Manufacturer: GE Healthcare
Brand: Carescape, Pdm
Model #: Carescape

Five previous MedSun reports were filed last year. Resolution from GE is still pending. Over fifty PDM, Carescape modules are sitting in a box in storage, which have not been deployed to clinical use since receiving them. Unable to obtain the update or definite time line to when the problems will be resolved. The previous MedSun reports filed were for:
1) NIBP Hardware failure with PDM
2) NIBP Issues with PDM and Tram
3) Rebooting issues in PDM
4) SpO2 issues with PDM
5) Temp Issues with PDM

Manufacturer response for Physiological Monitor Module, PDM (Carescape)
Released software upgrade for Solar 8000i. Upgraded monitors at the hospital. Put PDM’s (Carescape module) back into clinical use into a small pod of the OR’s as a pilot. PDM’s experienced the same failures as mentioned in the MedSun reports filed. Pulled devices out of use. Alerted GE. Solution still the hospital is pending a response from GE, with no update or timeline since. The PDM’s have been out of clinical use for ~ 1 year at this time.


Type: Solution Warmer
Manufacturer: O.R. Solutions, Inc.
Brand: Or Solutions
Lot #: 1208001
Cat #: ORS-100

Staff description: "RN noted Lactated Ringer's had leaked into the solution warmer through the sterile drape. Upon inspection, I noted and circled a 5mm tear in the drape. The tear was not uniform throughout, appeared more like a "melted tear." The attending surgeon, Dr. was made aware. The drape was placed into a biohazard bag, along with the package insert. The solution warmer was sent to BIOMED for a maintenance check.

Check of the warming device showed no malfunction. With temperature set at 105F, the actual temperature at the center of the basin measured 105.8F. Maximum observed temperature around the edge measured 108.4F. The inside of the basin had residue that appeared to be pieces of melted drape material. When the device is first turned on, the edges of the basin get extremely hot before the thermostat sensor gets up to the temperature set point. If there are folds in the drape, heat is not effectively transferred from the water to the bottom of the basin, allowing hot spots to develop. All of our other warmers show signs of drape melting on the bottom of the basin.

Anytime the sterile drape leaks, there is potential for patient infection. No patient injury has been reported so far. If the bottom of the warming basin had better heat distribution this problem could be minimized. Using a drape material with a higher melting point would also help.

We have had this problem repeatedly over the past few years. At least 5-6 times that I can remember that it looked like a melting issue. We have had puncture issues with the drape caused by sharp objects, but that is clearly operator error. Unfortunately, in most of the previous cases the drape was not saved (they are usually contaminated with blood).

OR Solutions maintains that melting only occurs when the drape is not properly seated in the basin and filled with water, but when you put a flat sheet of plastic into a deep rectangular basin, there is no way to avoid folds in the plastic. While in some cases, operator error may have contributed to failures, several incidents happened with well trained individuals who paid attention to the instructions and are very familiar with the units.


Type: Guide Wire
Manufacturer: Abbott Vascular Devices
Brand: Hi-torque Balance Middleweight Guide Wire, 0. 014", 190 Cm, Hydrocoat
Model #: REF 10011780J-HC
Lot #: 9031781
Cat #: (01) 0 8717648 02598 3
Other #: (17) 110228 (10) 9031781 (91) 3167

The device that failed is an Abbott Hi-torque balance middleweight.014, 190cm cardiac cath guidewire. During the procedure, staff was unable to advance a stent over the wire. Staff was able to advance a balloon over the wire, so they did that, and ballooned the vessel. They then took the balloon out and again tried to advance a stent over the wire. Again, they were unable to advance a stent over the wire. Staff removed the wire and noticed that the wire has an irregular "thickness" along its length that prevents a stent from being passed over the wire. The "thickness" almost looks like some sort of a "welding bead" in that it is an area were the wire's metal thickness is greater than it should be.

Device 1:

Type: Tourniquet
Manufacturer: Stryker Instruments
Brand: Smartpump
Model #: 5920-11

Device 2:

Type: Tourniquet Cuff
Manufacturer: Stryker Instruments
Brand: Color Cuff
Model #: 5921-24-135

Patient sustained 750 estimated blood loss during the procedure. MD stated tourniquet did not perform, possibly due to stents in Patient's leg, or due to equipment failure.

Device 1:

Type: Table, Surgical
Manufacturer: Stryker
Brand: Vertier Surgical Table
Model #: 0788-300-0005
Other #: Clin Eng Sticker "Loaner 4 4/09"

Device 2:

Type: Handpiece, Surgical Table
Manufacturer: Stryker
Model #: 0788-30-001

During surgery the patient was initially placed in trendelenburg position using handpiece. Since the handpiece did not work, they had to operate the table by plugging it in and using the control panel manually. After initial procedure they attempted to reverse trendelenburg position to supine and the handpiece would not work still, so they manually operated again from the control panel (the operations specialist was called and the control box was operated manually to get the patient out of trendelenburg into supine). The patient was then placed into lithotomy. Shortly after this, the head of the bed started moving up and down independently, with no one operating either the control box manually or with the handpiece. The potential for harm was the patient's airway could have been compromised, still under general anesthesia and on a ventilator, or other injury could have occurred, back strain etc. After removing the patient from the OR table, the team attempted to place the bed into a neutral position and the HOB snapped off and broke. This unit was a loaner and had a safety check by clinical engineering prior to use.

FDA Comment: Please see recall information below:


Type: Scalpel, Retractable Safety
Manufacturer: Cardinal Health, Inc.
Brand: Allegiance
Other #: Size 11

Retractable Scalpel #11 was used to cut a VAC sponge dressing. The scalpel opened and locked in position as expected for the first cut. It was then retracted and locked in place. The scalpel was picked up a second time by the physician, who passed it from Left hand to Right hand. During passing, the palm of the right hand was stabbed by the blade. At that time, the physician noticed that approximately 1/3 of the blade had slipped out into an exposed position, without any pressure on the Red retract button. The physician also noted that the blade did not retract as it lacerated the hand; it was in a locked position.

The physician's impression was that the red button, which retracts and locks the blade, did not function as expected. The blade should not have slipped out of the retracted position.



Type: Automated Syringe Filling System
Manufacturer: Baxa Corporation
Brand: Rapid-fill Automated Syringe Filling System

After the spinal block was placed for the scheduled Cesarean section, the patient was inadvertently administered Succinylcholine instead of Ephedrine. The patient became paralyzed and had awareness of difficulty breathing for about 60 seconds. The patient required a brief period of intubation and ventilatory support. The patient recovered satisfactorily from anesthesia.

Investigation: The Rapid-Fill Automated Syringe Filling System (ASF) automates on-line label printing by printing the label information and cutting the finished, labeled syringe from the strip. The label is affixed to one-half of the syringe barrel so that gradations on the syringe barrel are legible and it does not impair the ability to check the medication dosage. The ASF is used to fill and label syringes of Ephedrine (violet-colored label) and Succinylcholine (fluorescent red-colored label). The labeled syringes of Ephedrine and Succinylcholine are stored in the same drawer of the Pyxis unit. A staff member removed the syringe labeled "Succinylcholine" from the Pyxis and administered it instead of the ordered dose of Ephedrine. When the syringe is in the position to allow visualization of the gradation markings on the syringe barrel, only the white-colored backside of the label is visible. Apparently, the staff member did not check the printed medication label prior to administration. A root cause analysis of this occurrence will be completed. An interim measure has been implemented. A yellow-colored sticker that states "Warning: Paralyzing Agent" is affixed to the white backsides of the Succinylcholine labels before they are stored in the Pyxis. There have been no other complaints with this device other than there were some issues with a batch of syringes where the label went over the markings on the syringe.

Device 1:

Type: Omnicell Drug Sys
Manufacturer: Omni Cell Cabinet and PC
Brand: Omnicell Drug Sys
Model #: 344

Device 2:

Type: Omnicell Drug Sys
Manufacturer: Omni Cell Cabinet and PC
Brand: Pc Box For Color Touch
Model #: OSCT

Nurse entering in user ID on the Omnicell via keypad and shocked her. Then Omnicell shut down. The pop was heard by several staff members and witnessed by them as well. The shock pushed her back from the Omnicell.


Type: Software, Surgical Scheduling, Documentation, And Charging
Manufacturer: PICIS, Inc.
Brand: Picis Caresuite
Other #: PICIS 8.0 Service Package 12

PICIS locks up during patient care documentation at the "save" function. PICIS locks up only at the save function, allowing RNs to continue to document critical patient data only to discover at the end of the case, that no data will save. In order to get out of the patient chart, the computer must be re-booted. All patient documentation is lost. Nurses are forced to do their best guess as to surgical times, implants, medications, etc and re-chart the entire document. This is a safety issue for patients; RN staff direct their attention from the surgical field to the computer and spend a great deal of time trying to get the software up, and re-chart all the data. This is a healthcare safety issue because guessing what you previously documented live in a surgical environment puts RN staff at great risk for a patient care error, and an omission of critical patient surgical information, thus putting their RN License at risk.

This has occurred with multiple procedures and patients. Our facility has struggled with this issue for months. Information Specialists from our facility reported this issue to PICIS in February 2009. The issue has not been resolved, as of yet, and appears to be getting worse.

We have considered going back to paper documentation for safety, but our electronic PICIS scheduling, documentation and charging system is so ingrained in our processes, it would cripple us to stop now. This ongoing software program leaves us in a difficult position - due to the risk of data loss. The current Government is demanding Electronic Documentation as a Health Care Industry Cost initiative. We desire to be in the spirit of this order. Please assist us in resolving this issue so we may move forward in the spirit of patient safety and accurate electronic documentation.



Type: Bed, Air Fluidized
Manufacturer: Kinetic Concepts, Inc. (KCI)
Brand: Kinair
Model #: 40030A

Smelled electrical burning scent. Found motor casing to be very hot on Kin Air low air loss bed. Un-plugged bed immediately, removed patient from bed, removed bed from room, replaced bed with a new regular ICU bed. Company called.

Manufacturer response for Bed - Specialty, KinAir
Upon inspection of bed, one of the blower motors on the right side had ceased, overheating the outer casing, and damage occurred to the double insulated power cable.

See device images:

bed motor casing

bed motor casing label

bed control keypad



Type: software, laboratory system
Manufacturer: Ortho-Clinical Diagnostics, Inc.
Brand: Vitros 5.1 Chemistry System


Clinical lab chemistry analyzer was to have new software version pushed by the company. The company pushed an old version and disabled the analyzer. The equipment was inoperable for over four hours, which would delay any patient testing.


Type: analyzer, chemistry
Manufacturer: Siemens Healthcare Diagnostics Inc.
Brand: Advia Centaur XP
Model #: XP

False positive results reported on five patients. Tests involved were Hepatitis B Surface Antigen, Hepatitis B Core Antibody, and Hepatitis C Antibody. Testing suspended. Vendor service called in to evaluate instrument; no specific cause found. Hepatitis testing sent out to reference laboratory. Corrective reports issued. Appropriate providers notified.



Type: analyzer, chemistry
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Model #: CENTAUR

Hepatitis A IgM reported as reactive incorrectly. The supervisor realized there was an increase in equivocal and reactive patients. QC (quality control) acceptable, but levels changed; assay failed recalibration. Stopped analyzing the assay on Centaur 3 and moved analysis to Centaur 2. The assay calibrated, with a new reagent pack (lot# 131) and diluent 2 (lot# 33802)and QC was more consistent with past operation. The situation seemed better, but assay was still not performing as in the past. Siemens service was called in to check the instrument and another company was in to check the water system. After service and trying a new lot of diluent 2, it was determined that the old lot of diluent 2 (used only on Hepatitis A IgM) was the problem. We notified Siemens of the problem and sequestered the bad lot of diluent 2 (lot# 33802).

Initially it appeared to be the reagent causing the problem with the analyzer. More follow up by the staff with the vendor revealed that it is a maintenance issue. Device is under full contract with Siemens medical. Several parts were replaced within the system to eliminate the problem. Follow up with pathology will continue.



Type: Ventilator
Manufacturer: Cardinal Health

During transportation of a patient from one critical care unit to another, the Avea ventilator's battery unexpectedly died after less than five minutes. The ventilator was immediately removed from service and patient was placed on a different Avea ventilator. No adverse outcome to the patient.

Biomedical Engineering received the ventilator and replaced the battery, charged the battery and the ventilator passed testing. The ventilator was placed back in service. A biomed technician recently attended service school sponsored by the manufacturer. The manufacturer suggested adding the procedure of testing and cycling the batteries every 180 days. This was not being done every 180 days and so this step was added to the preventive maintenance task list for the ventilators.


Type: ET Tube Holder
Manufacturer: Integra Biotechnical LLC
Brand: Universal Bite Block
Model #: 11160
Cat #: 11160

While on an ET tube, patient was coughing and ET tube was displaced. When clinical staff tried the release lever for the ET Tube Bite block it would not release. Patient's sats became worse and the lever would not release. It took two people to get it off. Pt had to be reintubated. Health Professional feels the release needs to be stronger and bigger. It became jammed and there was not much leverage for the Health Professional when trying to get it released.

Manufacturer response for ET Tube Holder, Universal Bite Block
They were informed of the scenario of the device failure and were not requested by the Clinicians to come in house for a follow up meeting but have been cooperative.


Type: Universal Neonatal Heated Ventilator Breathing Circuit
Manufacturer: Teleflex Medical Incorporated
Brand: Hudson RCI Concha Therm
Model #: Concha Therm
Lot #: 02324
Cat #: 380-88

Inspiratory breathing limb came into contact with the expiratory limb which caused the inspiratory limb to melt at the contact point. This caused the circuit to leak. Both limbs have heated wire inside, which could cause the melting to occur during contact.

Manufacturer response for Universal Neonatal Heated Ventilator Breathing Circuit, Hudson RCI
No response.


Type: expiratory filter water trap
Manufacturer: Cardinal Health
Brand: Avea disposable expiratory filter with water trap
Model #: 11790
Other #: Part # is: 11790

The issue is with the AVEA disposable water trap which is a disposable ventilator water trap to be used with the AVEA ventilator. On eight known occasions, the water trap easily fractured (broke) off at the connector site for the expiratory hose. In all cases, this disabled the ventilator from delivering air, and patients had to be manually ventilated until replaced, putting patients at potential risk. In several instances, a clinician just "bumped into it" and in other instances the clinician was connecting the vent circuit when the said piece easily fractured.

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