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U.S. Department of Health and Human Services

MedSun: Newsletter #33, February 2009

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Newsletter #33, February 2009

Articles

Mission Hospital Receives Ernest Amory Codman Award

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Mission Hospital, a MedSun site in Mission Viejo, California, was named a 2008 recipient of the 12th annual Ernest Amory Codman Award by The Joint Commission. The hospital was recognized for its initiative to improve care for seriously ill patients in the emergency department or on medical-surgical floors rather than in the intensive care unit (ICU). The program uses a specialized nurse-driven rapid response team to reduce deaths associated with non-ICU cardiac/respiratory arrests by bringing the necessary staff to the patient’s bedside.

Named for the physician regarded in health care as the “father of outcomes measurement,” the award showcases the effective use of performance measurement by health care organizations to improve the quality and safety of health care. It was presented in November during The Joint Commission and Joint Commission Resources Annual Conference on Quality and Safety in Chicago.

According to a statement released by The Joint Commission and Mission Hospital describing the winning program, the initiative is especially relevant given the national trend in which seriously ill inpatients are at greater risk of mortality when they occupy medical-surgical beds or are held in emergency departments because of a shortage of ICU or telemetry beds. After reviewing 2 years of data, Mission Hospital’s Resuscitation Committee determined that better awareness of and attention to the risk of cardiac/respiratory arrests for non-ICU patients could reduce the number of incidents along with mortality rates. Among the achievements of the program were a decrease in cardiac or respiratory arrests outside the hospital’s ICU from 36 to 16 during a 1-year period, and a decrease in the associated mortality rate for floor code patients from 62 percent to 23 percent.

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Power Injection of MRI and CT Contrast Media

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FDA has received reports discussing vascular access device rupture under high pressure. The ruptured devices included central venous catheters, implanted ports, extension tubing and I.V. administration sets. Ruptures occur when the injection pressure is too great for the vascular access device to withstand. The articles found in the Additional Information section below have been collected from a variety of sources to provide you with information on this topic, as well as with recommendations on how to prevent these errors.

A recent MedSun report (also featured in this month’s Highlighted Report section) addresses this very issue. In this reported event, the I.V. tubing split from internal pressure upon introduction of power injection contrast media.

Additional Information:

Power Injectors Put I.V. Lines Under Pressure. Melissa Eakle, MSN and Susan Lange, MPH. Medical Device Safety.

http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/UCM064667.pdf

Reminders from FDA Regarding Ruptured Vascular Access Devices from Power Injection. Medical Device Safety.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070193.htm

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Important Information on Tubing Misconnections

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Luer fittings, connectors, and locks can easily connect many medical devices, components, and accessories. Unfortunately, because they are so easy to use, clinicians may mistakenly connect the wrong devices, delivering a substance through the wrong route. These errors can cause serious injuries and death. The items found in the Additional Information section below have been collected from a variety of sources to provide you with information on this topic, as well as with recommendations on how to prevent these errors.

FDA has developed a 2009 Medical Device Safety Calendar as a means to educate healthcare professionals about these dangerous events. The calendar provides images depicting twelve different misconnection cases in addition to recommendations on ways to prevent these errors. Please visit the FDA Luer Misconnections website to download or print the calendar to use in your healthcare facility.

You are also encouraged to visit the Educational Materials page for a newly posted webcast entitled, “Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events” sponsored by KidNet and presented in November 2008.

Additional Information:

Luer Lock misconnections can be deadly. FDA Patient Safety News. December 2005.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=46#6

Education, Evaluation are Key...Sentinel Event Alert Compels Hospitals to Address Tubing & Catheter Misconnections. Cruise,C. Association for the Advancement of Medical Instrumentation (AAMI), Biomedical Instrumentation and Tech. Vol 42(6). Dec. 2008
http://www.aami-bit.org/perlserv/?SESSID=24b2b52fc78ce4c839884a2e5085643c&request=get-document&doi=10.2345%2F0899-8205-42.6.469

Tubing Misconnections – A Persistent and Potentially Deadly Occurrence. The Joint Commission Sentinel Event Alert. April 3, 2006.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_36.htm

FDA Nurse Consultants Publish Article on Luer Connector and Tubing Misconnections. FDA MedSun website. June 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=15#1

Tubing Misconnection Errors Widely Recognized as Significant Patient Safety Issue. FDA MedSun website. September 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=17#3

A Look at MedSun’s Enteral Feeding Misconnections Survey. FDA MedSun website. September 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=17#4

Blood Pressure Monitor Tubing May Connect to IV Ports. Institute for Safe Medication Practices (ISMP) Medication Safety Alert! June 12, 2003.
http://www.ismp.org/newsletters/acutecare/articles/20030612.asp

Problems Persist with life-threatening Tubing Misconnections. Institute for Safe Medication Practices (ISMP) Medication Safety Alert! June 17, 2004.
http://www.ismp.org/newsletters/acutecare/articles/20040617.asp

2009 Medical Safety Calendar (featuring Luer Misconnections). FDA Luer Misconnections Website.
http://www.fda.gov/cdrh/luer/

Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events. MedSun website: Educational Materials. November 19, 2008.
http://www.fda.gov/cdrh/medsun/AudioConf_files/LuerConnectorMisconnections/index.html

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Safely Implementing Health Information and Converging Technologies

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The Joint Commission

Users must be mindful of the safety risks and preventable adverse events that the implementation of health information technology (HIT) and "converging technologies" - the interrelationship between medical devices and HIT - can create or perpetuate. The Joint Commission has provided some suggested actions to prevent patient harm related to the implementation and use of HIT and converging technologies.

Additional Information:

Safely Implementing Health Information and Converging Technologies. The Joint Commission Sentinel Event Alert. December 11, 2008.
http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_42.htm

Joint Commission Alert: Prevent Technology-Related Health Care Errors.
http://www.jointcommission.org/NewsRoom/NewsReleases/nr_12_11_08.htm

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24/7 Peer Support Program Helps Staff Deal with Emotional Impact Following Adverse Events

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SafetyShare Newsletter, Premier Inc.

The Peer Support Team model provides structured peer-based support services for healthcare providers after an adverse event. It was developed and implemented at Brigham and Women's Hospital. By having this model in place, healthcare providers can avoid pursuing more formal forms of support services through the Employee Assistance Program (EAP) or mental health services.

Additional Information:

24/7 Peer Support Program Helps Staff Deal with Emotional Impact Following Adverse Events. SafetyShare Newsletter, Premier Inc. December 2008.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/12-08-full-txt.jsp#story-08

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Practice Advisory for the Prevention & Management of Operating Room Fires

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American Society of Anesthesiologists

The incidence of operating room (OR) fires is difficult to determine, due in part to the lack of a mandatory national reporting system. Some estimates suggest that between 50 and 200 OR fires occur in the United States every year, with as many as 20% of reported fires resulting in serious injury or death. This advisory provides recommendations to healthcare providers on preventing and managing OR fires.

Additional Information:

Practice Advisory for the Prevention & Management of Operating Room Fires. American Society of Anesthesiologists. 2008.

http://www.asahq.org/publicationsAndServices/orFiresPA.pdf

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LabNet

Falsely Elevated Glucose Readings from Maltose-Containing Drugs

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Institute for Safe Medication Practices (ISMP) Nurse Advise-ERR

A number of cases have been reported in which falsely elevated blood glucose levels resulted in inappropriate insulin administration and subsequent hypoglycemia, coma, and even death. The falsely elevated readings were caused by a device interaction in patients receiving medications that contain maltose or metabolize into maltose. ISMP provides recommendations on preventing these errors. FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) also address this issue. Please see all resources in the Additional Information section below.

Additional Information:

Falsely Elevated Glucose Readings from Maltose-Containing Drugs. Institute for Safe Medication Practices (ISMP) Nurse Advise-ERR. Volume 6, Issue 11. November 2008.

http://www.ismp.org/Newsletters/nursing/Issues/NurseAdviseERR200811.pdf

Icodextrin (marketed as EXTRANEAL) and point-of-care glucose monitoring: A Dangerous Drug-Device Interaction. FDA Center for Drug Evaluation and Research (CDER) Drug Safety Newsletter. Summer 2008.
http://www.fda.gov/downloads/Drugs/DrugSafety/DrugSafetyNewsletter/ucm109178.pdf

Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product. FDA Center for Biologics Evaluation and Research (CBER) Website. April 2008.
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm

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HomeNet

Medical Device Recalls - DeVilbiss Model 515A Oxygen Concentrator

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FDA Recall

Date Recall Initiated October 30, 2008

Date Posted December 30, 2008

Recall Number Z-0617-2009

Product
DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities.

Code Information
Model 515ADS - serial number range A561137DS - A562049DS; Model 515ADZ - serial number range A538908DZ - A538924DZ; Model 515AKS - serial number range A542879KS - A543722KS; and Model 515AKZ - serial number A501627KZ.

Recalling Firm/Manufacturer
Sunrise Medical
100 Devilbiss Dr
Somerset , Pennsylvania 15501-2125

For Additional Information Contact Customer Service 800-338-1988

Reason For Recall potential for sieve beds to have been incorrectly assembled

Action
On 10/30/08, the recalling firm began to telephone customers of the problem. The recalling firm followed up with Urgent: Medical Device Recall letters, dated 11/7/2008. The letters requested that users cease the use of the affected device and immediately contact their provider to make arrangements to have the Concentrator replaced. The firm has set up a toll free line to assist customers with identification of affected units and the return process.

Quantity in Commerce 428 units

Distribution Worldwide Distribution --- USA including states of AL, CA, FL ,GA, IN, IL, MA, MD, MI, MS, NC, NE, NH, NM, NY, PA, SD, TN, TX, VA, and WI, and countries of Canada, Columbia, Germany, Mexico, Netherlands, Singapore, and United Kingdom.

Additional Information:

DeVilbiss Model 515A Oxygen Concentrator Recall. FDA Recall. December 30, 2008.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=74999

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KidNet

Webcast: Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events

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Please visit the Educational Materials page for a newly posted webcast entitled, "Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events" sponsored by KidNet and presented in November 2008.

Also visit the various resources featured in this month's Articles section, which address tubing misconnection issues and recommendations on how to prevent these errors.

Additional Information:

Important Information on Tubing Misconnections. FDA MedSun Website. February 2009.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=33#3

Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events. MedSun website: Educational Materials. November 19, 2008.
http://www.fda.gov/cdrh/medsun/AudioConf_files/LuerConnectorMisconnections/index.html

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Highlighted MedSun Reports

Highlighted Reports

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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.


GENERAL HOSPITAL

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

Problem:
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

Problem:
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

Problem:
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
Brand: SYMBIQ

Problem:
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

Problem:
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.

Device:
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

Problem:
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

Problem:
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.


OPTHALAMIC

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

Problem:
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


ORTHOPEDIC

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

Problem:
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.


ANESTHESIOLOGY

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

Problem:
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

Problem:
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.


PHYSICAL MEDICINE

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

Problem:
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.


GENERAL & PLASTIC SURGERY

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

Problem:
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

Problem:
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

Problem:

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.


CARDIOVASCULAR

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

Problem:
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

Problem:
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.


RADIOLOGY

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

Problem:

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

Problem:
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.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=33#2

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Medical Device Problem Summaries

Summary of MedSun Reports Describing Adverse Events: Large Volume Infusion Pumps and Issues Resulting In Over-infusion

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Over the past year, MedSun has received 20 adverse event reports of large volume infusion pumps and issues related to over-infusion. These reports are associated with five manufacturers: Cardinal Health (11), Baxter Healthcare Corporation (5), Hospira, Inc/Abbott Laboratories (2), Smiths Medical (1), and Sigma International (1). The reports were submitted by 16 user facilities between January 1, 2008 and January 1, 2009. The most frequently reported device problems were:

•Over-infusion (20)

One report involved a patient death, 1 report of injury, 12 reports indicate a malfunction, and 6 reports do not indicate the event report type. The following patient problems were reported:

•Overdose (15)
•Breathing difficulties (1)
•Low blood glucose (1)
•Electrolyte imbalance (1)
•Hospitalization required (1)
•Identified diagnosis (1)

Of the reports that listed patient age, 6 had a patient age listed as less than 21 years and 10 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 4 reports involved female patients and a total of 13 reports involved male patients.

These MedSun reports contributed to FDA awareness of the device problems. Reported events involving specific infusion pumps may, or may not, be involved in the recall(s) listed. Please note the lists of recalls below include recalls that could be related to issues with over-infusion from 2007 to present, and this report reviews Medsun reports from the last year.

•Cardinal Health Alaris Infusion Pump Module (formerly Medley Pump Module), Model 8100, Class I recall on October 29, 2007: During the manufacturing or servicing of the mechanism assembly, the occluder springs were misassembled (overlapping [nested], missing, bent or broken). If a spring is misassembled, there is a potential for inaccurate flow rate which may lead to a patient’s harm due to over-infusion.

•Baxter Healthcare Corp. COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Class I recall on August 15, 2007(updated recall information from June 21, 2007): A field service technician did not perform all of the hardware Recall: upgrades required in accordance with Baxter’s corrective action procedures related to eight open Colleague recalls. The service technician certified in the service documentation that the upgrades were done on the affected pumps even though the upgrades were not done. These incomplete upgrades were performed from May 22, 2007, through August 7, 2007.

•Baxter Healthcare Corp. COLLEAGUE and FLO-GARD Volumetric Infusion Pumps, Class I recall on June 21, 2007: On June 21, 2007, Baxter contacted their customers informing them that the company discovered, during ongoing quality control processes, that repair, test and inspection data sheets, including electrical safety data, were falsified. As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This may result in over infusion, under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can result in death. The company requested their customers to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for repeat inspections and servicing. Baxter will provide loaner pumps to customers that require them, free of charge.

[Note: The reports have been edited for clarity]




Large Volume Infusion Pumps and Reported Issues Related to Over-Infusion
Device Device Identifiers Event Description
Cardinal Health Alaris Infusion Pump Models 8100, 8015A patient was in the ED for chest pain and was on a heparin drip. The pump settings were checked by the nurse at the beginning of the morning shift which showed settings of heparin infusing at 17ml/hr, 18mcg/kg/hr, which was the appropriate dose. Approximately 2.5 hours later, the patient's 6 hour repeat PTT results were >150, which was up from the initial value of 28. The pump settings indicated no changes at that time. The doctor was notified of the lab results, and there was no order to change the dose or the infusion rate of the heparin. Approximately 1.5 hours after the PTT results were received, the heparin bag appeared to be abnormally empty to the nurse. The pump was checked by the nurse, and there were no changes in the settings. However, when the nurse checked the total volume infused, the pump stated 216.57ml. The total volume infused indicated an infusion rate of approximately 24ml/hr. A second nurse checked the pump display and verified the calculation discrepancy. The pump was removed from service. The patient was scheduled for a procedure later that afternoon. The doctor was notified of the issue and there was no change to the patient's treatment plan. There was no patient harm.
Cardinal Health Alaris Infusion Pump Model 8015 Patient receiving TPN at 80 ml/hr. Infusion stopped at 0430 to draw labs. Nurse restarted infusion and thought that rate was set at 80 ml/hr with approximately 2000 ml still in bag. Approximately 2 hours later, pump alarming and TPN bag empty. Pump taken out of service. When event/error log downloaded revealed that rate had been set at 880 ml/hr. Concern that there may be keypad bounce that is not immediately evident to user. Pt developed a-fib and was transferred to ICU had no long term harm.
Cardinal Health Alaris Infusion Pump Model 8100 Programmed IVPB at 100 ml/hr for a total volume of 250 ml at 0900. The infusion was completed at 1100; however the total volume on the screen show 45 ml left. Main IVF supposed to be 75 ml/hr but patient was receiving 100ml/hr. BioMed assessment: The pump operation and accuracy were verified in biomed and all tests were within specifications. The pump module will normally continue to pump for the duration of the calculated time as programmed prior to switching back to the main IV rate; however, this was not the problem. The device was returned to the manufacturer:
multiple tests were conducted and the pump operated according to specifications.
The conclusions: The pump appeared to have operated within specifications. No malfunction is believed to have occurred. The root cause of the reported problem is unknown. Based on this, the educators will share this report and review the loading and infusion methodologies for the pump. No patient harm.
Cardinal Health Alaris Infusion Pump Model 8015 55 ml Fentanyl syringe delivering 4 ml/hr (200mcg/hr) syringe was started and approximately 2.5 hours later, the syringe was found to be almost empty. Patient stable post event. Biomedical Assessment: Problem: Reported problem says: 60ml Fentanyl syringe set to deliver at 4ml/hr started and approximately 2.5 hours later the syringe was empty. The drug infused too quickly. It should have taken 15 hrs to deliver 60ml's. Corrective Actions/Recommendation: The event log from the PCA module shows that it was set to deliver 20 ml/hr instead of the 4 ml/hr as indicated by the nurse. There were no errors in the error logs for either the PCU or the PCA module. The pump functioned properly, but was set at the wrong rate.
Cardinal Health Alaris Infusion Pump Model 8100 Pump programmed to run at 125 ml for two hours for a total infusion of 250 ml. The IV infused completely in approximately 1 hour.
Biomedical Assessment: Testing in Biomedical Engineering found the LVP module functioning properly. There were no errors in the error log. The operation log shows a number of rate and volume to be infused changes during the course of the day, but there is nothing conclusive as to what actually happened.
Cardinal Alaris Infusion Pump Models 8100, 8000 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.
Device:
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.
Cardinal Health Alaris Infusion Pump Model 8100A bag of potassium (30 MEQ k in 100ccNS) was hung. The nurse programmed the pump for the medication to go in at 25 cc/hr. When the nurse went to release the roller clamp, it was noted that all of the fluid, except for approximately 30cc had infused. The nurse immediately rolled the clamp back down and called in the resource person to double check the pump, and notify her of what had happened. She verified the pump was set up correctly. The pt was having frequent PAC's and PVC's prior to this incident and continued to have them after. There were no other adverse effects all VSS. All of the IV tubing replaced and a new bag of potassium rehung.
Cardinal Health Alaris Infusion Pump Model 8100Patient was ordered a medication bolus followed by a drip (gtt) at 18.4cc/hr. A bolus was given and a gtt was started immediately afterward at 1145am. The pump module kept beeping "air in line". The tubing was taken out of module several times in an attempt to get air out; however, there were only very small air bubbles that would not normally cause the pump to alarm. Upon attempting to remove the air bubbles, the clamp (tubing) was opened and the medication ran wide open into patient. This caused the patient to receive approximately 4 hours worth of the medication in 1 hour. Once I realized how low the volume in the bottle was and what had happened I immediately shut off the gtt. Notified pharmacy and the Charge Nurse. Biomed was notified of the issues I was having with the module and picked up the pump for further evaluation. The physician was notified and orders were received to stop the medication gtt and restart in 4 hours. No patient harm.
Cardinal Health Alaris Infusion Pump Model Medley (8100)Initially Alaris pump screen showed Heparin infusion at 5 ml/hour with appropriate drip chamber flow. Nurse noted drip chamber started to free flow without pump beeping and screen still reading 5 ml/ hour. Patient received approximately 5,000 unit bolus of heparin (50 ml). Infusion stopped and pump removed from service. Patient without apparent injury. Follow-up indicates that the pump had passed the occluder testing just prior to the event, and subsequently failed the test when the pump was tested after the event. The pump has since been sent back to the company for corrective action. The hospital has a total of 1,114 Alaris Large Volume Pump modules which are managed and serviced for the hospital by a third party distributor. The pump distributor has completed occluder testing of 1046 of the LVP modules, as of this date, using the latest protocol provided by Alaris. Pumps which fail the occluder testing are returned the distributor's District Office where the failure is verified, and failed pumps are then returned to Alaris for X-ray inspection. Of the 1046 pumps which have been tested, 80 LVPs have failed the occluder test, or 7.65%.
Cardinal Health Alaris Infusion Pump Model unknown The Alaris pump was set to deliver 65 ml/hr of packed red blood cells for a total volume of 260 ml over 4 hours. Approximately 2 hours later, the pump was found to be alarming with notification for "air in line". Total volume had infused in 1 hour and 50 minutes instead of 4 hours.
Cardinal Health Alaris Infusion Pump Model Gemini PC-2TX Infusion pump was set to infuse at a rate of 2 ml/hr to deliver 48 ml in 24 hours. Infusion started at 12:30 pm and at 23:15, there was a fluid side occlusion, 100 ml bag of Intralipids was empty. Performance tested unit for rate and volume accuracy. Pump is operating according to the manufacture's specifications and was returned to service.
Baxter Healthcare Corporation Infusion Pump unknown A patient's cardiac rhythm changed from a sinus rhythm in the 80's down to the 40's, and the blood pressure increased to 200's/100's. The patient was observed and all drips were checked; pump C on the IV pump had failed. The screen said pump failure and it had apparently gave the patient a bolus of Levophed. The tubing was pulled out and another pump was used. The patient's heart rate and blood pressure returned to normal after a few minutes.
Baxter Healthcare Corporation Infusion Pump Colleague 3CX A 250ml lipid infusion was to run over 12 hours. Seven hours after the infusion was started, the infusion pump detected air in the tubing. The bag was empty. The pump settings were correct - 21ml/hr for 250ml total. The pump still showed 119ml were left to be infused. A triple pump was used and the other channels were working correctly. The lipids were infusing through channel B.
Baxter Healthcare Corporation Infusion Pump Syringe pump, AS50 Syringe pump programmed to run lipids at 0.2ml/hr. Syringe changed out and new lipids to run at the same rate over 24 hrs. Approximately 85 minutes later the pump alarm went off. At this time the syringe that had 4.2ml of lipids was now empty.
Baxter Healthcare Corporation Infusion Pump Flogaurd 6301 TPN hung on pump at 2121 to infuse at 19 CC/HR. Bag empty (approx 500CC) at 0330. Biomed performed functional test per service manual. Found no problem.
Baxter Healthcare Corporation Infusion Pump Colleague 2M8163 Patient was receiving TPN infusion at a rate of 45 ml/hr. A new infusion bag was hung and the IV pump's volume setting was changed accordingly. The rate was allegedly unchanged, but 45 minutes later, the patient became confused and tachypneic. The pump was found to be operating at 700 ml/hr. The pump was discontinued and sent for inspection. Insulin therapy was started and lab tests were sent on the patient to compensate for the over-infusion. The patient recovered.
Hospira, Inc/Abbott Laboratories Infusion Pump Plum pump, Lifecare 5000 New bottle of integrellin started at 12cc/hr (100cc bottle) approximately three hours prior to the bottle being empty. Integrellin bottle was empty with pump still running. Pump removed from service immediately.
Hospira, Inc/Abbott Laboratories Infusion Pump Plum A+ Plum "A+" pump. An Insulin drip had been hung at a rate of 2.5 cc/Hr. Approximately two hours later the bag was empty. The patient did not present as if he had received that much insulin. The pump showed that 90cc had infused. Concerned that the pump is malfunctioning.
Smiths Medical Infusion Pump Medfusion 3010A Male infant on ECMO . Infant received approximately 40ml of heparin via syringe pump, instead of 0.4ml. The medication eas heparin 100u/ml. Patient had elevated ACT levels, but no apparent bleeding and no change in cranial ultrasond. Heparin discontinued temporarily until ACT levels returned to normal.
Sigma International Infusion Pump Spectrum Patient was to receive Septra at 500ml/hr for a 1036ml bag in which there was 36ml of Septra and 1000ml of D5. The primary IV (.9NS) fluids were set to run at 125ml/hour. When the secondary IV infusion rate of 500ml/hour was supposed to have switched back to the primary rate of 125ml/hour; it didn't, and the secondary rate of 500ml continued for an amount of time unknown to the nurse. The infusion of the Septra that was mixed in the D5 took 2hrs and 45minutes to run, when it was programmed to run over 2 hours. This was due to the fast rate and subsequent running in of some of the primary fluids at the same time as the secondary fluids (Septra/D5). Between the secondary rate of 500ml/hr of running the primary fluids (.9NS) for a time, and the primary fluid (.9NS) dripping in with the Septra/D5, the patient received approximately 240-345ml of NS at the rate of 500ml/hr. Staff unsure if flow rate was set incorrectly or if something happened with the pump. This could be prevented by staff checking the patient when the secondary fluids should be finished, and also confirming the pump set up is correct. The nurse should also be sure that the primary fluid bag is hung low enough to not flow in at the same time as the secondary infusion.
Clinical Engineering evaluation: A review of the event log within the pump correlated to the event information. The staff, per order attempted to infuse a secondary infusion at 500ml/hr. Operational testing of the pump in the stated configuration showed that without the primary line clamped, siphoning would occur. Current pump software does not prompt the user to monitor and clamp, if necessary, the primary line when infusing a secondary infusion above 300ml/hr.
Staff to be advised to monitor any secondary infusions for siphoning of the primary bag as evidenced by primary line drip chamber activity specifically at rates nearing or above 300ml/hr.

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Summary of MedSun Reports Describing Adverse Events with the Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery System

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Over the past 10 months, MedSun has received 5 adverse event reports associated with the M-Style Vacuum Assisted Delivery System, which includes the Mushroom Cup, and the M-Style Cup, which is manufactured by Cooper Surgical. The reports were submitted by 4 hospitals between 2007 and October 2008. The two main reported device problems were:

•Three reports of the physician unable to release the suction cup from the infants head after application of suction. Manual release of the suction cup was needed in these cases.
•Two reports of the suction cup popping off during the procedure.

The patient injuries are listed below:

•Two reports mentioned small marks left on the infants head
•Another report mentioned a 4th degree perineal laceration experienced by the maternal patient, and lower APGAR scores of the delivered infant due to the longer delivery time.

Although not listed in these reports, hematoma injuries, either cephalohematoma or subgaleal, are potential rare complications associated with vacuum-assisted vaginal deliveries.

These MedSun reports contributed to FDA awareness of the device problems. FDA follow-up with the manufacturer resulted in a Class II Recall of the device.

On September 17, 2008, the M-Style Mushroom Cup Vacuum Assisted Delivery System was voluntarily recalled by Cooper Surgical because the Vacuum Assisted Delivery System may have a loss of vacuum, or the cup will not release from the baby's head. A loss of vacuum may delay delivery and require the use of forceps and/or c-section for delivery. An inability to remove the cup from the head may delay delivery and/or prevent the user from applying forceps if necessary. This may result in serious injury or death to the baby. Included is a link which addresses the problem and lists the products which are covered.

The two recall numbers are: Z-1887-2008, and Z1888-2008.





Cooper Surgical M-Style Vacuum Assisted Delivery System
Device Device Identifiers Event Description
Cooper Surgical/M-Style Mushroom Cup Vacuum Assisted Delivery System Ref # 10007LP Lot # 60734 After vacuum delivery, the cup did not easily release from infants head after pressure was released. Cup removed manually by physician. Small vacuum mark noted to infants head.
Cooper Surgical/M-Style Vacuum Assisted Delivery System Ref # 10007LP
Lot # 65910
Physician placed the M-Style Mityvac at 10 mm Hg then pumped it up to 50 mm Hg one minute later. The physician pulled for 20 seconds until delivery. Once delivered, the vacuum was released, but the doctor was unable to remove the suction device from the baby's head for approximately one minute. Finally, the doctor had to place their finger under vacuum head to release the suction. Small marks noted on the head of the baby. After a few hours, the marks were no longer visible, and the baby was discharged home with no further complications.
Cooper Surgical/M-Style Vacuum Assisted Delivery System Catalog # 10007LP After obtaining consent for a vacuum delivery, the mushroom cup Mityvac was placed and position was checked. Over the next two contractions, the physician did attempt to pull with the vacuum and there was one pop-off. The vacuum was not maintaining adequate suction beyond a level of 10-15. The vacuum was removed and a new replacement pump was obtained as well as the vacuum cup and tubing. The new vacuum was placed and again position was checked. Steady progress was made and the vacuum was maintained at approximately 45-50 in the green zone and there were no pop-offs. The cup and tubing was not retained and the lot number was not recorded. Early this year, a recall notice was received from Cooper Surgical regarding a recall of specific lot numbers of the disposable vacuum assisted delivery products. We did pull from inventory 12 items from one affected lot number.
Cooper Surgical/Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System Model # 10057 Mityvac was used to assist with delivery in appropriate range (40-50cmHg) and traction was applied through one contraction. With the second contraction, the cap disengaged from the rest of the vacuum and maintained suction on the fetal head.

After the failure of the vacuum extraction device, forceps were needed for the delivery, and there was a maternal perineal 4th degree laceration as a result. To remove the attached extraction cap from the infant's head, the physician had to insert her finger under the cap and slide it fully around the cap edge.

No additional intervention was required for the infant, but there were lower APGAR scores due to the longer delivery time.

It is believed that the device was defective, especially due to the fact that the cap did not release easily, and the doctor stated that the vacuum applied was in the green range. Undue force was not applied.
Cooper Surgical/Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System Model # 10057
Lot # 57913
Upon SVE (Sterile Vaginal Examination) patient complete and prepared for delivery. MD applied vacuum and vacuum popped off; re-applied, and while the MD was pulling during birth, the vacuum broke. A new vacuum was applied and another pop-off occurred. MD allowed patient to push without vacuum, and vacuum re-applied; vacuum disengaged.

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Updated February 1, 2009

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