Highlighted Reports
MedSun: Newsletter #26, July 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 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.


Device: Syringe, Contrast Injector; Optiray
Lot# P080A
Manufacturer: Covidien Mallinckrodt

Device: Injector, Contrast; Liebel Farshein Injector
Model # 90330 d
Manufacturer: Covidien Mallinckrodt

Problem: While performing IV angiogram the power syringe cracked down the side. The injector settings were: 25 ml/20ml/sec and 249 psi were reached according to the injection archive. The injector was set to max out out at 1000 psi. The injector did not reach the maximum output. We have had multiple incidents with these syringes on several different injectors. This injector was service by the company 6 days after the event and was found to be working properly within specifications.


Device: Pacemaker, External Temporary
Model# 5388
Manufacturer: Medtronic Inc.
Problem: A post cardiac surgical patient was pacer dependent in the surgical intensive care unit several hours after completion of surgery, when the physiologic monitoring alerted clinical staff to the fact that the patient was asystolic. Immediate examination of the patient found the temporary external pacer to be completely turned off. CPR was performed while another pacer could be found. Upon connection with the replacement pacer the patient was returned to the expected rhythm. It is known that there was no indication of a low battery three hours prior to the incident and the 9 volt battery that was in use when the incident occurred was found to be within normal charge limits, at 8.75 volts, after the incident. Since the patient was totally pacer dependent and not active, and no one else was in proximity of patient when the event occurred, it appears the unexplained power off of the pacer caused the adverse event. Manufacturer indicated intent to examine and test the pacer as well as battery.

Device: Module, Physiological Monitor, NIBP; Datex Ohmeda M-PRETN-01 Measurement Module
Model# M-PRETN-01
Manufacturer: GE Medical Systems Information Technologies
Problem: During preoperative anesthesia machine checks, the doctor noted a NIBP "cuff occlusion" error message on machine S5 monitor display. The M-PRETN multiparameter vital signs module would not allow noninvasive blood pressure measurement. The doctor checked all cables and cuff tubing for kinking, and there was none. This error has been reoccurring on several of these modules and has required repair by the manufacturer. In every case the manufacturer has replaced the NIBP interface PCB to correct error. The problem with the remaining modules keeps occurring, which causes delay and or cancellation of surgical procedures. The manufacturer has been notified of these failures, but has not resolved this ongoing issue. This current report is for two additional module failures.

Device: Cooling/Warming Blanket; Maxi-Therm Lite
Model# 876
Lot# 8346
Manufacturer: Cincinnati Sub-Zero Products Inc.

Device: Hypo/hyperthermia Unit; Blanketrol II
Model# 222
Manufacturer: Cincinnati Sub-Zero Products Inc.

Problem: Patient was on cooling blanket. The blanket sprang a leak, soaking the bed and the patient. The leak occurred near the location where the 2 tubes mate with the blanket surface.

Device: Monitor, Physiological; Dash 3000
Manufacturer: GE Medical Systems Information Technologies
Problem: Monitor alarmed. Nurse pressed silence button on monitor and monitor went blank. She turned monitor back on. A while later monitor alarmed again. Again, nurse pressed silence and monitor went blank. Logs were downloaded and sent to GE.


Device: Pump, PCA; LIFECARE PCA 3
Manufacturer: Hospira Inc.
Problem: Even though the PCA pump was plugged in, the battery light still remained on. Once the alarm went off, the battery light would not turn off. The PCA pump was replaced for another one. Biomedical engineering determined that a faulty power supply was the source of the problem.

Device: Catheter, Pleural Drainage; Pleurx Pleural Catheter
Lot# L79256
Catalog# 50-7000
Manufacturer: Cardinal Health
Problem: A Cardinal Pleurx catheter was placed for the drainage of pleural fluid. About two weeks later, the catheter was removed because there was leaking around the catheter site and the catheter had become dislodged. It was subsequently determined that there have been 10 other patients that have had Pleurx catheters placed at our facility during a three month period of time that have had complications that include leakage around the catheter site, infection at the catheter site, or the catheter becoming dislodged. Clinicians involved have expressed that the complications described above may be related to catheters not adhering to the skin as they were designed to do. Also, information provided to us by the manufacturer (Cardinal Health) indicates that excessive amounts of glue used during the manufacturing process allowed the adhesive to come in contact with the cuff material.

Device: Phototherapy System, Infant; Wallaby 3 Photo Therapy Unit
Manufacturer: Respironics, Inc.
Problem: Parents report that they were awakened by a shattering noise, "a huge bang" "like a window shattering." The parents went to the room where their infants were and observed glass on the floor (the infants were receiving phototherapy). The yellow light on Wallaby unit was flashing and the green light was on. The unit appeared to be operating correctly and the second bulb had turned on automatically and phototherapy was being delivered. The parents reported unplugging the unit and cleaning up the glass. No report of injury. The unit was plugged back in to continue therapy. The parents called the hospital to provide notification of the event. The home was visited by a staff member. The involved wallaby unit was recovered and returned to the manufacturer for evaluation. Manufacturer response for Phototherapy, system, infant, Wallaby 3 Photo Therapy Unit: Per a report forwarded from the company – Unable to confirm complaint of ‘bulb exploded.’ There is no evidence, shards, or parts internal of unit. However there is a bulb enclosure installed with a missing element. Unit also appears to have been dropped. The front panel enclosure is cracked/marred/damaged. The outer metal enclosure is dented on the left rear corner. Replaced bulbs with known good bulbs and ran for 24 hours total (switching both). No operational issues were found/noted. QA will hang onto and archive the suspect bulb for a period of one year. Unit is serviceable and will be returned in service for repair after investigation completed and unit released.

Device: Tray, Sterilization; FlashPak
Catalog# 9020
Manufacturer: Symmetry Medical

Device: Indicator, Sterilization Process; Comply Steri Gage
Model# Class 5
Lot# 201301SP
Catalog# 1243
Manufacturer: 3M

Problem: When items are placed within these pans to flash sterilize, the indicators do not change color to indicate that the sterilization process has taken place.

Device: Tubing, IV, Infusion Set; MiniLoc
Model# 0632010
Manufacturer: Bard Access Systems
Problem: The nurse received a phone call from the patient's mother stating that the patient had pulled their Bard MiniLoc Safety Infusion IV Set out. The nurse went to the room immediately and noticed Huber needle line was broken at the connector site. The nurse de-accessed and re-accessed immediately and obtained a positive blood return and flush. There were no further complications. Clinical Engineering examined the device and it appeared that the tubing came unglued from the luer lock portion. There was no evidence of a crack or break in the tubing. The Bard MiniLoc Huber needles have been having many issues hospital-wide with the tubing detaching from the luer lock portion of the device Bard has been slow to respond, but are now addressing the issue. In response to this issue, Bard informed us that they changed the glue process approximately 4-6 weeks ago, and will replace our old lots with new ones. We are currently trialing new products to replace this device, and have issued a notice to all users to warn them of the continuing issue.


Device: Analyzer, Blood Gas; ABL 835 Flex
Model# 835
Manufacturer: Radiometer America, Inc.
Problem: Lab technician was processing six inpatient blood gas samples and noticed that all samples had resulted with low readings. Delta checks for equipment were within normal range. Results were communicated to providers. Five of the six patients had treatment plans changed because of the low readings. It was then discovered by lab personnel that there was a clot in the blood gas machine, and that the results that had been processed were incorrect. Providers were notified and appropriate changes were made.


Device: Electrode, ESU, Suction Coagulator; LectroVac
Model# E2610-6
Lot# 125150
Manufacturer: Covidien Valleylab

Device: Electrode, ESU, Suction Coagulator; LectroVac
Model# E2610-6
Lot# 124355
Manufacturer: Covidien Valleylab

Problem: During a procedure in December 2007, the suction coagulator handpiece being used with the electrosurgical unit became permanently activated. The doctor operating the handpiece was aware that it was active and was able to remove the handpiece without causing harm to the patient. The handpiece was sent to the manufacturer for evaluation. It was found that the foam springs of the hand piece had failed, causing the on/off button to remain permanently activated. On January, 2008, a similar event occurred. Again, the surgeon was able to remove the handpiece without causing harm to the patient. This handpiece has been sent to the manufacturer for evaluation. Results from the manufacturer's evaluation are not yet available. Manufacturer response for ESU suction coagulator hand piece, LectroVac: Failure/misalignment of internal foam springs.

Device: Light Source, Surgical; Stryker X8000
Manufacturer: Stryker Endoscopy
Problem: No injury or incident with any patients. The scrub tech noted that the end of the laparoscope, when connected to the Stryker light source, seemed to become extremely hot very quickly. After cases were completed, we tested the light source and scope with a gown. The light source was set at 90 and turned on with the end of the scope on a gown. We found that this made a hole in the gown in 10 to 15 seconds. We found this alarming, and contacted the manufacturer's representative. The representative came to the hospital, and we demonstrated this to him. He stated that he was aware of issues with the end of the light cord becoming hot, but stated that he was not aware of an issue with the end of the scope also becoming hot. He further stated that the light source should never be set above 50, due to causing increased heat. We tested the same light source, cord, and scope with the unit set at 50 and after 2 minutes there was no hole or damage to the gown. Note that the light sources were set to 90 upon installation and had not been adjusted down since we had no idea that this was an issue or that the unit should not be set above 50 per the rep. We would like manufacturer guidelines on this made available if possible.

Device: Scissors, Surgical; Metzenbaum
Model# 810-01-21218
Lot# 44691
Manufacturer: Tri-anim Health Services, Inc.
Problem: During a laparoscopic total hysterectomy, the insulation on the disposable scissor tip came off. It was retrieved from the patient's abdomen by the surgeon. This is the second occurrence of insulation failure with this particular lot number, and the entire lot is being pulled for return to the manufacturer.


Device: Intraocular Lens, Foldable; TECNIS
Other Device # CE0050
Manufacturer: Advanced Medical Optics, Inc.
Problem: The capsular bag was reinflated with viscoelastic. A foldable
acrylic lens was injected into the capsular bag and was allowed to unfold.
Although there were no visible defects of the intraocular lens, upon examination of the acrylic lens inside the injector, a 2-3 mm area of
the anterior surface of the intraocular lens had presented some opacification and
haziness. To avoid any visual disturbances, this specific intraocular lens was removed.
After removing the intraocular lens, there appeared to be a
possible posterior capsular opening. Therefore, to avoid any possible
extension, viscoelastic material into the ciliary sulcus (Healon) was included.


Device: Lithotriptor; Compact Delta
Model# Fluke 80K-40
Manufacturer: Dornier MedTech America, Inc.
Problem: The machine was turned on and passed the initial check; however, when the patient was positioned on the table; the device would not power up. The case was terminated, and there was no patient harm. The report from the vendor revealed they found a defective pulse transformer, bleed down resister, and also a defective drive power electronic PCB. All issues were repaired, and an overall system operation check was completed. The device was returned to service.

Device: Agent, Bulking, Injectable, for Gastro-Urology Use; Coaptite
Lot# 1007722, 1007300, 1004812
Manufacturer: BioForm Medical
Problem: The physician was unable to inject the bulking agent either because the agent was too thick or the needle was defective. Four boxes of this product were opened and none of them came out of the injectable dispenser.

Device: Catheter, Urinary, Temperature Monitoring; Temperature Management System
Other Device # 402484-00, REV.A, SCT1967
Manufacturer: Phillips Medical Systems

Device: Temperature Management System; Arctic Sun 2000
Manufacturer: Medivance, Inc.

Problem: The Arctic Sun 2000 temperature management system was used as a monitor during therapeutic hypothermia in a patient following an out-of-hospital cardiac arrest. The foley temperature probe, which used for monitoring the patient's temperature, was broken. The end connector piece was found to be missing. There did not seem to be any replacement cables available so the cable was used without the connector. The wires were inserted into the Artic Sun machine, and as a result, the patient's temperature was not accurate. The patient was overcooled to a temp of 29.9 degrees. He became hypotensive but did not have bradycardia or Osborne waves. The therapeutic hypothermia was discontinued and the patient was re-warmed.


Device: Catheter, Suction
Lot# 434501 or 432376
Catalog# 198

Device: Catheter, Suction; Ballard Trach Care "Y" ET ADPTS 6FR 2MM O.D. 12"/30.5CM
Lot# 414362
Catalog# Ref 196

Manufacturer: Kimberly-Clark Corporation
Problem: Intubated patient with an in-line suction catheter. The RCP noted air in the sleeve covering the catheter after suctioning. The in-line catheter was removed and replaced, but the RCP did not notice that the catheter was damaged. Chest X-ray later identified a foreign body in the patient's right mainstem/trachea. The patient underwent a bronchoscopy for removal of a 7 cm tip of suction catheter.

Device: Holder, Endotracheal Tube; AnchorFast
Other Device # 9788
Manufacturer: Hollister, Inc
Problem: Hollister redesigned the ETAD (endotracheal tube attachment device) to the AnchorFast to decrease complications of skin erosion; practitioners believe new design puts patients at higher risk of loss of airway for following reasons: smaller attachment points do not support the device on the face; removal of adhesive tape from upper lip causes the device to fall down on the face; anchor point too far from lip which creates opportunity for tonguing out ET tube; and they are not staying attached near as long as the ETADs were. The company rep. was informed of problems.


Device: Catheter, Ventriculostomy; External Drainage Catheter
Model# believed to be REF INS series catheter
Manufacturer: Integra NeuroSciences
Problem: Prior to MRI, gadolinium contrast material was mistakenly injected by MRI technologist into ventriculostomy external drainage catheter directly into ventricles of brain rather than into nearby IV access catheter. Approximately 17 cc's were injected and about 4 cc's aspirated back after error was recognized. Access port/luer connector on ventriculostomy tubing is reportedly compatible with syringe used for injecting intravenous contrast material. Warning label or coloring of tubing was not readily apparent. IV port taped near ventriculostomy port, causing increased risk for user error.

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