Highlighted Reports
MedSun: Newsletter #20, January 2008

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 October 1 through October 31. 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: Soda Lime Canister, Dragersorb Lot# ARXN-F002 Other Device# Ref MX00004 Anesthesia Machine, Fabius GS; Breathing Circuit, Other Device# Ref 5030AJ9
Manufacturer: Drager Medical AG and Co. KGaA; Vital Signs, Inc.
Problem: During a routine procedure (using general anesthetic) with the patient breathing spontaneously through an LMA (laryngeal mask airway), the anesthesia machine alarmed: low fresh gas flow, negative pressure while in the pressure support mode. Return to spontaneous mode caused the alarm to stop. After the procedure it was found that the soda lime canister had created a small negative pressure leak which started the alarm. Soda lime particles were noted to be escaping the sealed portion of the canister and getting into the breathing circuit and into the machine. The seal inside the canister was inserted sideways within the canister, allowing the soda lime particles out of the sealed portion. The machine had passed all safety/leak checks that morning.

Device: Bag, Resuscitation, INdGO Manual Resuscitator Model# PBMV Lot# 7141147
Manufacturer: Nellcor, A Division of Tyco Healthcare Group
Problem: Patient tachypneic on ventilator. Patient desaturated, respiratory therapist hand bagged the patient and physician unable to auscultate breath sounds; no chest rise. Endotracheal tube pulled, unable to Bag Valve Mask (BVM) pt. Pt reintubated, no breath sounds/no chest rise, cardiac arrest, CPR started, Laryngeal Mask Airway (LMA) placed, unable to oxygenate/ventilate pt. Pt reintubated again with no breath sounds/no chest rise, bag changed out, able to oxygenate/ventilate pt with new bag. This bag had been working correctly earlier in the day when the patient was suctioned and taken off the ventilator. After the event, the bag was examined, and it was noted that the duck valve for positive pressure did not flip up. The duck bill of the internal diaphragm dislodged.

Device: Ventilator, Anesthesia Machine, Aestiva Model# 1006-9305-000
Manufacturer: Datex-Ohmeda, Inc.
Problem: The green vent knob will not up regulate values for all settings and modes. Instead, it will max at the pre settings/fall continuously to a lesser setting, i.e. clockwise motion of the knob fails. For instance, you can only go down a menu, not up, and sometimes it will go to one higher number but for only a moment then reset. Problem solving the machine to no avail. Power reboot, no avail. This however was not done for more than a few seconds, since the pt was under anesthesia. Hand venting for the case. The repair was done by a Datex-Ohmeda representative with the replacement of the display electronics, which included the controls and related circuitry.


CARDIOVASCULAR

Device: Defibrillator, R Series
Manufacturer: Zoll Medical Corporation
Problem: Nurse was performing daily defibrillator test and pacer test. Pacer test failed. Device brought down to Biomed for evaluation. Biomed was able to duplicate the problem. When in Pacer Mode, cannot increase or decrease rate or output settings. Code Readiness Test Log - Failed. Also noticed error message 115.

Device: Kit, Transducer, Blood Pressure, MEDEX Pressure Tubing Lot# 1147063 Catalog# MX9604A Other Device# V-link -V2847
Manufacturer: Smiths Medical
Problem: Multiple trauma patient in ICU Arterial line tubing disconnected/broke around the seam and patient lost approx 100 cc’s of blood. No follow-up treatment was required except to replace the tubing. There were other occurrences of tubing failure, however, the tubing was not saved. We conferred with the company representatives and decided to remove that lot number, because each faulty pressure line was from that lot.

Device: Catheter, Ablation, Cardiac, Chilli II Model# M00490310 Lot# 9777695 Catalog# 9031
Manufacturer: Boston Scientific Corporation
Problem: The patient was undergoing an ablation for atrial flutter. The MD placed an 8 French sheath in the right groin for ablation purposes. The sheath was easily placed and the ablation catheter was inserted without difficulty. However, when the MD tried to remove the sheath, the ablation catheter became “stuck.” The MD was unable to turn the sheath. No extra force was applied. Eventually, the catheter was able to be removed. The MD used another catheter to complete the procedure. There was no patient harm in this event. A manufacturer’s rep came to the Risk Management department a few days after the event to see the device, and will have the manufacturer send a mailing label to return the device for evaluation. Per the rep, they have experienced this kind of problem before, and are recommending MD’s to use a larger size sheath. The MD’s were notified and have already changed their practice to increase sheath size from an 8 French to an 8.5 French. To date, no other problems with the device have been reported by either the MD’s or the cath lab staff.

Device: Kit, Pressure Transducer Lot# 58304527 Other Device# Product PXVMP3X32
Manufacturer: Edwards Life-sciences, LLC
Problem: During the assembly process to place an arterial line, the transducer was not giving a reading on the monitor. The staff was unable to test and zero the monitor. Used 3 transducers of the same lot before getting another lot # that worked. All of the effected lot numbers were removed from the shelves and a notice was sent to other sister hospitals to remove this lot number.


GENERAL HOSPITAL

Device: Mattress, Air Flotation,Trinova Model# 7101
Manufacturer: Pegasus Airwave, Inc
Problem: Patient in room after returning from a procedure. Two RNs were pulling the patient up while a third RN held the sheet at the foot end of the bed. The Trinova mattress pump was hanging on the end of the bed by hooks, and fell off when the mattress moved. The pump fell on the top of the third RN’s right foot. She went to the Emergency Center and was X-rayed and given Tylenol. She was sent home with a prescription for Vicodin and crutches. Clinical Engineering looked at the Trinova mattress pump in question, and found that the hooks are too small to fit over the foot end of the hospital beds securely. Looked at Trinova pumps located on beds throughout the hospital and found that the same problem exists everywhere. Called the manufacturer and the service technician. They are installing the pumps between the mattress and footboards. Staff are moving them after they are installed. Sent notice to nurse managers to let them know to warn staff not to hang pumps on footboards. Since the time of this incident, Pegasus has followed up with a solution to place the pumps in a holster type device that hangs from the footboard.

Device: Catheter, PICC, Power PICC 5 Fr Lot# RERE0065
Manufacturer: Bard Access Systems
Problem: Patient came to clinic complaining of pain in his left arm starting at his elbow and radiating to his shoulder. Patient did not have any swelling signs or symptoms of infection at site. MDs paged and ordered PICC to be removed. Doppler studies ordered and patient was found to have deep vein thrombosis. Patient was sent to ER for treatment. PICC placed by Vascular service approximately one month prior (5 Fr., 18 G, double lumen, Power PICC).

Device: Pump, IV, Module Model# 8100BX01EE; Pump, IV, CPU Model# 8000BX03EE
Manufacturer: Alaris Medical Systems, Inc.
Problem: The RN was connecting an Alaris Large Volume Pump (LVP) module to the point-of-care (PCU) unit. When the two pieces were connected, the RN noticed the smell of smoke right away and noted a burned connector on the Alaris LVP. The RN disconnected the LVP from the PCU, tagged the two devices and notified the Biomedical Engineering department per hospital protocol.

The Biomedical and Clinical Engineering departments assessed the pump and noted the burned connector. This connector has a tendency to burn when it gets damp or bent. This has happened several times in the last few months. The hospital owns 1600 of these pumps, so we see this as a potential issue for patient safety because the burning connector could cause a fire if undetected.

Alaris (owned by Cardinal Health) has been replacing these connectors for free, as the events happen, with a new design of the connector that is more rugged. We have not had any problems with the newer connectors. We recommend that Alaris recalls the old connectors that have a tendency to burn, and replace them with the new rugged connectors.

Follow-up reveals that:
•The original connectors are grey, and the new replacement connectors are black.
•The new black ones are apparently a harder plastic, so the pins do not bend as easily.

Other than that, there are no apparent differences between the old and new connectors. Our best guess is that the damage to the pins causes this because the plastic is softer on the old connectors; but it could be a combination of both fluid and damage to the pins.

We have had:
•45 documented incidents of the sparking, smoking or burning of these connectors in the past 3 years.
•246 connectors have been replaced by Alaris at their expense. When we send the pumps in for other repairs, they automatically replace the IUI connectors as well.
•We have also replaced another 290 connectors ourselves on pumps - in this case we purchased the connectors from Alaris.
•We still have another 2720 pumps that have old IUI’s (5440 IUI’s total). We believe this is a fire hazard.

Device: Pump, IV, Module, Medley Model# 8100BX01EE
Manufacturer: Alaris Medical Systems, Inc.
Problem: Order written to start insulin IV. Tubing was flushed and connected to central line of patient. One hundred unit insulin in 100cc normal saline bag spliced with new tubing. Tubing attached to Large Volume Pump (LVP) of Alaris Point-of-Care Unit (PCU) infusion pump. Placement of tubing correct. Door on LVP would not latch properly. Message on alarm “flow stopped, open door.”
•Placement of tubing in arm checked multiple times and
•attempts to close door properly failed multiple times.
•IV bag noted to be empty after this time.
Assume IV had run into patient (all 100 units of insulin infused into patient during this time). Patient was monitored and given proper medications to control overdose. Patient is okay.

Clinical Engineering replicated problem. The problem was found to be a use error in combination with device mechanical malfunction. The following was determined:
•The set screw on the latch for the LVP was loose, and
•the spring on the latch was loose as well, so the latch did not properly close the flow stop clamp when the door was opened. This only occurred when the flow stop clamp was placed into the pump in the open position. The clamp is supposed to be closed and then placed in the pump; however, the pump still should have closed the clamp automatically as the door was opened, but it did not.
•Additionally, the roller clamp was left open while the RN was setting up the pump. Informed nurse manager that the roller clamp should be used as the primary means to prevent free flow.

Gave educational posters to nurse manager. He will follow up with staff. Biomed will fix LVP and run through diagnostic tests.

(For information about a recent Alaris recall of this device model go to http://www.cardinalhealth.com/alaris/brochure/PumpModuleRecallCustomerLetter.pdf)


GENERAL SURGERY

Device: Battery Pack, Surgical Instrument Model# REF 4115 Lot# 05286
Manufacturer: Stryker Instru-ments
Problem: In approximately April 2007 the Stryker Rep for the hospital told the OR staff they could extend the life of their Stryker electric handpiece (System 4/System 5) battery packs/batteries by flash sterilizing them instead of using Sterrad sterilizer. Following this change in process, when batteries were sent back to Stryker for replacement, Stryker began reporting to us that our battery packs were found to have water in them. As a test, we flashed a battery pack and then placed it in the Sterrad sterilizer and the load failed, indicating there was moisture in the load. We then opened the battery pack and found not only moisture but also extensive corrosion of the battery. We opened several other battery packs and also found extensive corrosion of the batteries as well.

Device: Stapler, Skin, Insorb 20
Manufacturer: Incisive Surgical
Problem: Over the past month or so, approximately six cases of broken suture line have been reported. It was investigated and determined that in one case the patient had to return to OR due to leaking. In addition, after discussion with staff and physicians it was noted that numerous events of suture line breaking during surgery occurred and simply were not reported as the physician was able to resuture while the patient was still open. Company indicates that they believe that the product was compromised during transport at extremely high temperatures. Records indicate that the need to verify temperature indicator was not provided on purchase and that the suture is removed from the box with the indicator on it at our warehouse and stored, therefore, no check of the temperature indicator was being done.

Device: Suture, Disposable, Meniscal Repair Kit Lots# 0704310, 0702265, 065006, 0507080 Other Device#ref 228322, ref 228321
Manufacturer: DePuy Mitek
Problem: Four sutures from the DePuy Mitek RapidLoc meniscal repair kit (PLA Tophat braided absorbable suture and 12 degree curved needle) broke as the surgeon was loading them. Another kit was obtained from inventory. Two of the failures involved reference number 228321 and included lot numbers 0704310 and 0605006. Another failure involved reference number 228311 and had lot number 0702265. The final failure had a reference number of 228322 with a lot number 0507080. This issue was reported to the manufacturer sales representative.

Device: Kit, Hernior-rhaphy, Custom Autosuture Lot# 00E2597
Manufacturer: United States Surgical Corporation
Problem: The items in the box are correct; however, what is pictured on the box is not what is inside the box. This discrepancy lead to surgical case cancellation. Surgeon under the assumption that the wrong equipment supplies were in the kit based on the picture.

Device: Attachment, Surgical Robot, Maryland Bipolar Model# 420172 Other Device# da Vinci S System; Attachment, Surgical Robot Prograsp Forceps Model# 420093 Other Device# da Vinci S System
Manufacturer: Intuitive Surgical, Inc.
Problem: This is the second report of small black pieces of an unidentified foreign substance found during a robotic procedure. It was noted that there were some collisions between the instruments, which occurred prior to the discovery of the pieces. Post procedure, there was some visible damage to the instruments. One of the possibilities was that the black debris could have originated from the instruments. Collisions of the instruments are avoided in the OR by correctly placing the port locations and positioning of robotic surgical arms. Surgeons must be aware of where instrument shafts are for both robotic and non-robotic instruments, and the patient side assistant and/or other personnel in the room should be making the console side surgeon aware of when collisions occur, and what devices are colliding.


NEUROLOGY

Device: Shunt, VP Arachnoid Cyst-Peritoneal
Manufacturer: Codman and Shurtleff, Inc.
Problem: The patient had a revision of a left VP arachnoid cyst-peritoneal shunt. The initial implant of the device was five years prior. According to the patient, an MRI diagnostic procedure was performed and since that time, the shunt has not worked.

Device: Programmer, VP Shunt, Hakim Catalog# 82-3121
Manufacturer: Codman and Shurtleff, Inc.
Problem: Patient had a VP shunt implanted for normal pressure hydrocephalus. A second surgery was done to reposition the shunt after a CT Scan. A third surgery was done to place burr holes due to recurrent hygromas. A fourth surgery was done to redo the burr holes and to occlude the shunt, again for recurrent hygromas. The surgeon could not explain the sequence of events and the failure of the shunts. This led to a manual testing of the shunt with a manometer which indicated a different pressure setting than had been programmed. A second programmer was used which resulted in a normal pressure setting. The surgeon opined that the programmer was malfunctioning and programming the shunt valve at an incorrect setting.


OPHTHALMIC

Device: Hand Piece, Phaco, Emulsifier,Turbosonic Phaco-emulsification Handpiece Other Device# turbosonic-375
Manufacturer: Alcon Labora-tories, Inc.
Problem: Patient undergoing cataract extraction by means of phacoemulsification. The emulsifier handpiece had recently come back from repair. It was flushed prior to use. During the operation, the handpiece sprayed debris into the operative field. The handpiece was removed, the eye was irrigated and as much of the debris as possible was suctioned out and sent to cytology for evaluation. A new handpiece was attached, which worked fine.

Device: Instrument, Vitrectomy 23 Ga Total Plus Pak Lot# 7024053x-2007-07 Catalog# Ref 8065750828
Manufacturer: Alcon Labora-tories, Inc.
Problem: During vitrectomy for retinal hemorrhage on a patient with diabetic retinopathy, a LitePipe and 23 gauge probe stuck in cannula. The retina detached and a scleral buccal was performed. The relationship between the retinal detachment and the sticking of the probes is unclear. Couldn’t dislodge the probes from the cannulas.


PHYSICAL MEDICINE

Device: Bed, KinAir Speciality
Manufacturer: Kinetic Concepts, Inc.
Problem: A staff member was turning the patient to their right side. The pedal on the KinAir bed indicated that the brakes for the bed were in the “locked” position. The bed started moving away from the staff member and the patient rolled off the bed and was caught by two of the staff members. The patient did not hit the floor and the two additional staff members proceeded to stabilize the bed to prevent it from continuing to roll away while the patient was lifted back into the bed. KCI was contacted and the company representative indicated that the wheels need to be parallel for the brake lock to work properly. Staff recommended that an additional label/warning be placed on the bed to alert hospital personal of the proper brake operation. KCI was notified of the labeling recommendations.

Device: Bed, KinAir Speciality
Manufacturer: Kinetic Concepts, Inc.
Problem: A staff member entered the patient’s room as the patient was about to slide from the KinAir bed onto the floor. The patient was laying on their right side and had their legs over the side of the bed. The two upper side rails were up. The staff member assisted the patient to the floor and then lifted the patient back onto the bed. The patient received a minor abrasion which was dressed. As part of the recurrence prevention discussion, staff indicated that the mattress of the KinAir bed is very slippery. The plan was to place the patient in close observation to keep them centered in the bed. Staff requested that the company be notified in regards to the slippery and unsafe mattress surface.

Device: Chair, Shower, Lumex Model# 7920 Other Device# 717076007597
Manufacturer: Graham-Field Health Products, Inc.
Problem: Patient called out from inside the shower. When the RN arrived she found the patient sitting on the edge (side) of shower chair that had collapsed. The leg of the shower chair had bent under itself. The patient stated she hit her self in the elbow and hip. The RN saw the patient supporting herself on the chair. The RN took the broken chair out of the shower and replaced it with a new one. The RN found no apparent injury to the patient’s right elbow or right hip. MD was notified and assessed the patient. Patient was okay. We believe the weight capacity of this shower chair was 400 lbs because a similar model 7921 has a 400 lbs capacity. The patient weight was well below this limit. There haven’t been any other reported incidents, but after examining more chairs throughout the hospital, I have noted that many of them have slightly bent and loose legs.


LABORATORY/DIAGNOSTIC TESTS

Device: Swab, Bacteria Sample, BactiSwab Lot# 538508 Catalog# 12100/12110
Manufacturer: REMEL, Inc.
Problem: The nurse pulled the product from the storage area. She removed the exterior packaging and noticed there was mold growing on the swab. The product was never used on a patient.

Device: Glucometer, Accu-Chek Inform System
Manufacturer: Roche Diagnostics Corporation
Problem: Patient arrived to Emergency Room unresponsive. Fingerstick blood sugar via Accucheck Inform glucose monitor result of 93. Saline lock started and blood drawn for lab. Lab blood sugar 32. Emergency Room staff concerned about difference in blood sugar results. Lab’s Point-of-Care Coordinator sent Accucheck Inform monitor to Roche to be checked out. Lab’s Point-of-Care Coordinator feels difference can be explained by the Emergency Room finger stick being a capillary draw, while lab results came from blood drawn from a saline lock.

Device: Analyzer, Chemistry, LX20 Phosphorus Reagent M705538 Phosphorus Kit 467868
Manufacturer: Beckman Coulter Inc.
Problem: The laboratory detected questionable patient results of phosphorus levels on the Beckman Coulter, Inc. LX 20, which could have led to possible misdiagnosis and inappropriate treatment. Upon investigation it was discovered that patients were receiving high level doses of AmBisome. This is a known problem which has been reported to Beckman Coulter, and which does not appear on their known interference list. The presence of AmBisome necessitated a change in procedure requiring completion of an ultra-filtration procedure before the assay could be properly performed.

Additional Information:

For information about a recent Alaris recall of this device model go to

http://www.cardinalhealth.com/alaris/brochure/PumpModuleRecallCustomerLetter.pdf


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