Highlighted Reports
MedSun: Newsletter #35, April 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 January 1 through January 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.


GENERAL HOSPITAL

Device: Bag, Enteral Feeding
Manufacturer: Covidien Kendall
Brand: Kendall (Kangaroo Enteral Feeding Bags)
Cat #: REF 773662
Other #: barcode 00388847736628

Problem:

Our new tube feeding sets will not prime properly. Covidien redesigned the set to change the connection tubing so that it cannot be used with a Luer lock syringe. This change eliminates the chance that a clinician might hook the patient’s feeding tube to an IV infusion by mistake. Since the new sets arrived in the units, the staff members have reported issues with priming the tubing. The product representative has visited each unit that reported a problem, re-educated staff on the proper technique and collected some sets that the staff deemed defective. Nonetheless, the problem persists. The staff states they have had to try two or three sets to find one that works. They must waste the feeding product as well as the set each time. The manufacturer has now pulled our existing inventory and replaced our product stock.

Device: Tubing, Iv
Manufacturer: ALARIS Medical Systems, Inc.
Brand: Smartsite Needle-free Valve PortAdd-on Burette Set
Cat #: 82114E
Problem:

A patient was receiving chemotherapy when an Alaris pump indicated air in line. On inspection by the nurse, it was noted that there was air in line all the way from below the drip chamber (which was half full) to the pump. The line had to be cleared of air.
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Manufacturer response for burette, Smartsite Needle-free Valve PortAdd-on Burette Set
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The rep was on site and is supplying us with a different type of buretrol to try. The staff report the buretrols are hard to spike. The rep feels that possibly the intake valves are not straight and are allowing air in.

Device: Set, Administration, Iv
Manufacturer: Alaris Medical Systems, Inc.
Brand: Latex -free Add-on Burette Set
Cat #: 82114E

Problem:

A nurse was priming a patient's chemotherapy tubing with normal saline when it was noted that there was fluid leaking from a hole in the bottom of the Alaris buretrol. Pharmacy was called. The pharmacist was able to re-spike the chemotherapy bag with a new buretrol. The chemotherapy was then administered as ordered without further incident.

GASTROENTEROLOGY & UROLOGY

Device: Ultrafiltration Drain Bag, 7 Liter
Manufacturer: B. Braun Medical, Inc.
Lot #: 7210511
Cat #: 07M18 or 08G18

Problem:

There was a leak from the side of the Diapact ultrafiltration drain bag. The spot was on the side of bag at the top fold, about two-thirds up. There were a number of reports involving the seven liter CRRT drainage bags from this facility where a bad lot was received. The mfr. had identified the bad lot in these old reports and had replaced them, but the bags continued to resurface. Somehow, the facility was re-supplied the same lot that was bad. B.Braun denied receiving reports of this problem with the defective bags from any other user facility.

Device: Hemodialysis Machine, Crrt/cvvh
Manufacturer: Gambro Renal Products, Inc.
Brand: Prismaflex
Problem:

Last summer, RN was taking care of patient with CRRT Prismaflex running continuously. There were reported "access pressures" issues with the patient and all possible nursing interventions were carried out to attempt to correct problem. The nurse then reported that the machine alarmed with a malfunction of the effluent scale. The machine shut itself down and would not allow any retesting to occur. The machine was sent to Biomed for inspection and a replacement Prismaflex machine was brought in to continue with the ordered therapy.

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Manufacturer response for Hemodialysis Unit, Prismaflex Machine
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Gambro assisted with testing on site and serviced the device at their location.

Device: Tubing, Insufflation
Manufacturer: Stryker Endoscopy
Brand: Pneumosure
Model #: 620-040-690
Lot #: 069408D
Cat #: 620-040-690
Problem:

Insufflation Tubing disconnecting at grey end (Distal end -connector to machine) causing loss of Abdominal Insufflation, which disrupted view during procedure. Will not reconnect and seal. Continues to lose pressure despite multiple reattachment attempts. Connection to trocar end also becomes disconnected when maneuvering telescope through the trocar. Connectors at both ends of insufflation tubing are lacking adequate connection.

Loss of insufflation disrupted surgeons view during hernia repair. Multiple reinsufflation attempts extended procedure. Fortunately, there was no bleeding at the time, but loss of insufflation at a more critical juncture of the procedure could have resulted in opening the patient. We believe this is a safety issue requiring immediate resolution.

Device: Hemodialysis Machine
Manufacturer: Fresenius Medical Care North America
Model #: 2008K
Cat #: 2008K
Problem:

Patient had bleed out of at least 1.5 liters of blood from a leaking venous connection that had become slightly disconnected. Further investigation found that patient had been placed on their back. Patient's wife had covered up their access site, and when the venous pressure alarm condition was reset there was not a confirmation of the venous pressure by staff. Apparently, the alarm condition was reset at an unknown pressure. Machine continues to operate at this unknown pressure once reset without any further notification to operator. Patient's wife called attention to the patient. The treatment was terminated. EMS was activated and the patient was moved to the floor. One and half liters of normal saline was pushed and CPR was started at the same time. Within four compressions the patient became responsive. At this point the ER staff from the hospital responded and transported the patient to the hospital ER for further evaluation and care. The machine operation was tested and appeared to operate normally. A call was placed to Fresenius Medical Care North America to report the problem. Further follow-up will be reported to Medwatch. Spoke with technical assistance to further evaluate testing methods. Machine does have a blood sensor that should give an alarm condition when at a zero pressure. This sensor was not tested at the time of incident. On another date I was called to the facility and had the charge nurse test this sensor with a zero pressure, and it appeared to still have almost a twenty second delay before the venous clamp engaged and the blood pump stopped.

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Manufacturer response for Dialysis Delivery System
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Further follow-up will be reported to MedWatch.

Device: Catheter Tray, Foley
Manufacturer: C.R. Bard Inc.
Brand: 100% Latex Free Foley Tray With Bard Ez-loc Sampling Port 16 Fr
Lot #: NGSH1823
Problem:

Unable to remove the foley catheter after balloon was fully deflated. We reviewed the issue with the manufacturer and were told that we should not be inflating/deflating the balloon prior to insertion, which we were doing. We sent instructions to the nursing floors to discontinue the practice of inflating/deflating prior to insertion. We contacted the company and were told that the problem was that the foley should not have been inflated prior to insertion, which was a common practice with earlier catheters.

Device: Tubing, Hemodialysis
Manufacturer: Medisystems Corporation
Brand: Readyset Hemodialysis Blood Tubing Set
Lot #: 8075108
Other #: D3-9642M9795

Problem:

Upon starting a dialysis treatment, the arterial transducer line tip was cracked and air was in the line. Treatment was stopped just as air was reaching dialyzer. Arterial pressures became high as blood was in the transducer line. Venous needle only had saline in line. System was disconnected from patient. New lines and dialyzer was primed and recirculated before the start of the treatment.

ORTHOPEDIC

REPORT HAS IMAGES/PHOTOS
Device 1: Implant, Acetabular Cup, Resurfacing System
Manufacturer: Smith & Nephew, Inc.
Brand: Birmingham Hip
Model #: 74120160
Lot #: 086149
Cat #: 60 mm

Device 2: Implant, Femoral Head, Resurfacing System
Manufacturer: Smith & Nephew, Inc.
Brand: Birmingham Hip
Model #: 74123152
Lot #: 08DW16616

Problem:

A Smith and Nephew Birmingham Hip Resurfacing System was being implanted in the patient. There is a range of new sizes and packaging that were just released. This was the first time using "new" product. The new product is color coded to indicate compatible size combinations. Mismatched components were placed in the patient. "Old" product is not color coded.

The surgeon expressed that he took additional steps such as meeting with the rep prior to the procedure to discuss the new implant sizes and what he expected to use for the case. He also expressed concern that there could be a mix-up as 2 products have the same numerical size but one fits a certain size head and another fits a different size head. He also felt the labels could be designed better to have the key information in the largest font. On these labels for example, the expiration dates are in larger font, and in this case were the same, so they gave the appearance that they "matched." The outer box label has some of the information on size compatibility on the face of the box and some on the edge, so the box has to be moved to see all of the key information. The label design could be improved to have key information such as compatible sizes listed in a largest font.

When new products/sizes come out, the existing stock should be marked for compatibility with the new sizes. There was no color coding on the 60mm cup. We would recommend label redesign using Human Factors principles to make the most important information the largest font. See images.

This picture displays the bottom of the box from the new labeling of a 60 mm acetabular cup from the Smith and Nephew Birmingham resurfacing hip system.  This picture has useful information to the user that can only be obtained if the user remembers to look at the bottom of the box.

This picture depicts the side of the box from the new labeling for a 60 mm acetabular cup from the Smith and Nephew Birmingham hip resurfacing system.  The labeling is surrounded by a brown rectangle to emphasize that brown labeling for an acetabular cup should go with brown labeling for a femoral head.

This picture has two different labels in it for two different products.  The top label is the old labeling for a 60 mm diameter acetabular cup from the Smith and Nephew Birmingham hip resurfacing system.  It has an expiration date of 2013-04 and states that it should only be used with a 54 mm size head. The bottom label depicts the new labeling for a 52 mm diameter femoral head.  The labeling is surrounded by a brown rectangle to emphasize that brown labeling for a femoral head should go with brown labeling for an acetabular cup.  It also has an expiration date of 2013-04.  Considering the old labeling did not have brown color on it and there was no compatibility chart for the user to refer to, the user thought that these two products from picture three were compatible because the expiration dates are the same and in a large font.



Device: Reamer
Manufacturer: Synthes USA, Inc.
Brand: Reamer Irrigator Aspirator (Ria)

Problem:

When ambulating from the commode the patient felt a snap in her left femur and lowered herself to the ground. X-rays showed a left subtrochanteric femur fracture. The injury was repaired with an intramedullary gamma nail placement to the left femur. The left femur is the site of the bone graft harvest performed using the Synthes RIA bone grafting system.

Device: Impactor, Femoral
Manufacturer: Smith & Nephew, Inc.
Brand: Journey
Model #: 74012811

Problem:

OR discovered the plastic on the Smith and Nephew femoral implant impactor is chipped and cracked. This is the second event involving the same type of impactor. This report is being submitted for documentation purposes only. The company is aware of the problem and is addressing the issue.


GENERAL & PLASTIC SURGERY

Device: Harmonic Shears
Manufacturer: Ethicon Endo-Surgery, Inc.
Brand: Harmonic Ace
Model #: ACE36E

Problem:

Harmonic ACE curved shears received pad damage during intraoperative use - appeared melted. Surgery was laparoscopic supra-cervical hysterectomy. The sales rep was present and took the damaged product.

Clinical Engineering was called by the OR and informed that the return plate of the disposable shears had been damaged during the case. There wasn't any harm, but they wanted the device checked to make sure it is working properly. The salesman took the damaged disposable. He retrieved all 4 hand controllers because there wasn't any indication as to which was used. Completed safety and functional tests of the generator as per manufacturer's specifications. Completed functional test on hand controllers. Phase Margin (Hz) range should be between 170-247. Impedance (Zr) range should be between 15 - 40. No issues identified. All hand controllers were operating within tolerance. Clinical Engineering called the Ethicon sales rep. He explained that the incident was caused by the hand controller being activated after the shears had cut through tissue causing both sides to touch. If this happens throughout the case it could have caused damage to the return plate.


CARDIOVASCULAR

Device: Introducer
Manufacturer: C.R. Bard
Brand: Bard Ssv Split Sheath With Valve Introducer System
Lot #: 526744
Cat #: 808700

Problem:

CST was scrubbed in and setting up for an implant. While the patient was being prepped she went to flush the safe sheaths she was given. She noticed the syringe that she picked up had a brown and sticky substance on it, which was not related to anything on the tray. She then had RCES called and asked to come to remove the product. RCES then had both sheaths removed, told the staff to reopen another tray, discarding the contaminated tray and equipment and asked the scrub tech to re-gown and glove. Nurse then had all the 7 FR sheaths from that lot # pulled and set aside as well as informed the company of the issue.

Device 1: Defibrillator, External
Manufacturer: Medtronic Emergency Response Systems
Brand: Physio-control Lifepak 12
Model #: LP12

Device 2: Defibrillator, ICD
Manufacturer: Medtronic Inc.
Brand: Virtuoso

Problem:

A code was called on a patient that was in SICU. The defibrillator pads were placed on the patient and the patient was being monitored by both the LP12 defibrillator and the patient monitor. Chest compressions were being administered and the staff reported that the defibrillator delivered a shock to the patient and attending staff without the shock button of the LP12 being pressed. The patient’s rhythm was regained and the staff reported a tingling in her arms. In order to deliver a shock during proper operation of the defibrillator three options must be selected:
1) the energy level from 1 to 360 joules,
2) the charge button, and
3) the shock button must be selected to deliver the set energy level.
After the energy level is set and the charge button is selected, the defibrillator will have an audible tone until the shock button is selected. If the shock button is not selected within 30 seconds the defibrillator automatically resets without discharging.

The unit was bought to Biomed and tested fine. The field representative was called to test the unit and it tested fine. Upon further investigation, it was found that the patient had an implantable cardioverter defibrillator that had initiated a shock.

Comment from FDA: This report is featured to demonstrate the importance of communication.

Device: Monitoring System, Hemodynamic
Manufacturer: Witt Biomedical Corporation
Brand: Xper Information System
Model #: Xper
Other #: Software version 1.1.1.1291

Problem:

This is one of three systems having the same issue. The system samples invasive hemodynamic pressures, upon review of a sampled pressure measurement, the technologist edited the measurements. After a few minutes, the system changed the edited pressures back to the pre-edited measurements. The system doesn't print out accurate information. Staff has to make notes and dictate the actual results. Company has stated that it is a known software problem. Philips updated the software in September to: 1.1.1.1291 and again in January 2009 to version 1.2.1474 to resolve the latest issue.
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Manufacturer response for Monitoring System, Hemodynamic, XPER Information System
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This system performance issue is a potential patient safety issue. Philips has escalated our issues through their system and has agreed to an on sight meeting on in January to develop a plan of action to address these problems.

Device: Debrillator, ICD
Manufacturer: St. Jude Medical
Brand: Atlas Plus Vr
Model #: V-193

Problem:

Patient had LVAD (HeartMate-2) placement. His ICD was initially implanted for primary prevention of sudden cardiac death 3 years prior. Preoperatively his device was noted to have normal function, however immediately post LVAD implantation; we were not able to establish telemetry with his ICD. Failure of telemetry with St. Jude ICDs due to radiofrequency interference from Heart Mate II LVADs has been previously described in the literature (J.C. Matthews, M.D. et al., J Cardiovasc Electrophysiol, Vol. 18, pp 1107-1108, October 2007). The patient was seen and examined by an electrophysiology staff physician and deemed appropriate for a generator change to resolve this issue.


NEUROLOGY

Device: Holder, Head, Neurosurgical
Manufacturer: Ossur Americas
Brand: Halo Ring
Problem:

One specific lot of halo rings proved to be faulty in the manner that the threads on the ring were tapped too tightly to accept the ceramic pin without torque. There were a couple of previous patients that we noticed this problem on but the problem was so severe that the pins would not thread at all so the rings were not used and the pins never even got close to the patients head. No penetration. When this happened the ring was replaced and ensured that the pins threaded smoothly. The manufacturer has notified our facility that they have implemented several changes and corrective actions to their manufacturing process to correct this issue.

Device: Electrodes
Manufacturer: EMPI
Brand: Stimcare Carbon Cl Electrodes
Cat #: 199327-001
Other #: 814907 and 199327-001

Problem:

Patient underwent routine interferential electrical stimulation to left upper arm at 14 mA, same as previous treatments. She did not complain of pain during treatment, and no apparent skin abnormalities were noted upon removal of electrodes. However, the patient phoned the clinic later in the day reporting a blister from a burn in back of her left upper arm. She states it was about 2"x2", the same size as the electrode.

Of note, the re-sealable electrode storage bag had holes punched through the bottom portion of bag, to attach to it to the patients clinical chart (binder). The electrode pads had partially dried out in between treatments, due to the compromised integrity of the re-sealable bag. The dried electrodes had more electrical resistance, and are suspected to have arced and caused a thermal burn where it was applied to the skin. Our facility is no longer storing these bags in this manner. However, it is interesting to note that our facility had previously been storing bags in this manner for a long time, with no adverse outcomes. Clinical staff has also noted that the electrodes are not adhering as well as they previously did. The directions for use state that the electrodes can be used on the same patient for multiple treatment sessions, and that electrodes can be re-hydrated with a drop of water. Our facility is considering using new electrodes for each treatment, as a result of this recent incident.


ANESTHESIOLOGY

Device: Anesthesia Delivery System
Manufacturer: GE Healthcare
Brand: Aisys Carestation
Model #: Aisys
Other #: GE gas analyzer

Problem:

In the middle of the case the patient had to be bagged while the anesthesia delivery machine was changed out. The switchout involves a change in circuits and a Pedi-lite sensor. Anesthesiology was not aware that an upgrade for the carestation anesthesia delivery system was needed to take care of smaller children. We bought our machines at different times. The first ones were sent with the upgrade by mistake. The next order was not.

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Manufacturer response for anesthesia delivery system, Aysis
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Upgraded all of our machines to E-CAiOV so that they are standardized. Training given to staff on different circuits and sensors. Instructions for doing anesthesia on children smaller than 6 Kg

Device: Anesthesia Delivery Machine
Manufacturer: GE Healthcare, Inc.
Brand: Aisys Carestation
Problem:

Power switch caused machine to shut down. Had to change out machine in middle of surgery. This has happened in the past and GE related to us that they are having trouble with the power switch failing. GE advised us that when this is going to occur that the machine will give a visible display that it is going to shut down in 8 seconds. Then we should turn the switch to standby. Once the machine shuts down - wait for 10 seconds until compressed air is heard. Then the machine will reboot itself.


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