Summary of MedSun Reports Describing Adverse Events With Electrocardiograph Electrodes in Pediatric Patients and Related Reference
MedSun: Newsletter #28, September 2008

By Elizabeth Eydelman, Patient Safety Staff, 2008

From June 2007 to May 2008, MedSun has received 10 adverse event reports involving electrocardiograph electrodes associated with three manufacturers: Conmed Corporation (7), Tyco Healthcare Group LP (2), and 3M Company (1). The reports were submitted by 2 hospitals between June 2007 and May 2008. The two most frequently reported device problems are:

• Fluid Leak
• Loose-fitting nature of device

There are no MedSun reports involving a patient death during this time period. There are 6 reports that do not list the type of adverse event, 3 that list injury adverse event type, and 1 report lists malfunction as the type of adverse event. The most frequently reported patient problems are:

• Rash/Blisters/Erythema (7)
• Prolonged/Repeated Surgical Procedure (2)
• Skin Erosion/Drainage (1)
• Necrosis (1)

All of the reports feature pediatric and neonatal intensive care unit patients in each respective hospital. Of the reports that list patient gender, a total of 8 reports involve female patients and 1 report involves a male patient. These reports contribute to FDA’s post-market experience and understanding of problems associated with the use of these devices.

The chapter on Skin and Skin Care in the 5th edition of the Handbook of Neonatal Intensive Care (St. Louis: 2002) provides tips for skin care of preterm and term infants: (1) minimize tape use when possible by using smaller pieces, (2) utilize soft gauze wraps to secure probes and electrodes, and (3) remove adhesives slowly and carefully with warm water and cotton balls.

[Note: The reports have been edited for clarity]



MedSun Electrocardiograph Electrode Adverse Event Reports Received Between June 2007 and May 2008
Device Device Identifiers Event Description
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 WHEN CHANGING PATIENT'S LEADS, IT WAS NOTED THERE WAS SKIN BREAKDOWN UNDER THE LEAD ON PATIENT'S LEFT LOWER ABDOMEN.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 DURING A ROUTINE PATIENT ASSESSMENT AND THE REPLACEMENT OF THE ELECTRODES DUE TO THEIR SLIDING OFF, SMALL BUMPS WERE FOUND ON THE CHEST AND STOMACH, UNDERNEATH THE ELECTRODES. THE CHEST BUMPS WERE NOTED TO BE REDDENED AND ONE WAS BLISTERED. THE STOMACH BUMPS WERE NOTED TO RESEMBLE PIMPLES WITH WHITE HEADS.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 WHILE BATHING THE PATIENT, WHICH INCLUDED REMOVAL OF THE ELECTRODE LEADS, SMALL BLISTERS WERE NOTED UNDER ELECTRODE LEAD AREA ON THE CHEST AND ABDOMEN. THE BLISTERS ON THE ABDOMEN APPEARED TO BE OPEN.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE ECG LEADS CAUSED BLISTERS ON THE UPPER CHEST. THE BLISTERS WERE NOTED TO BE WORSE ON THE RIGHT SIDE OF THE PATIENT.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE PATIENT WAS NOTED TO HAVE SIGNS OF DRAINAGE AND SKIN EXCORIATION UNDER THE ELECTRODE.
Conmed Corporation/Electrocardiograph Electrode Lot: 0703051 THE PATIENT WAS NOTED TO HAVE A RED RASH UNDER TWO OF THE THREE ELECTRODES. IN ADDITION, YELLOW DRAINAGE WAS NOTED ON THE ELECTRODES THEMSELVES.
3M Company/Electrocardiograph Electrodes Lot: B 2008-09 AB ELECTRODES FAILED TO STICK TO THE SKIN OF A 5 WEEK OLD MALE, STATUS POST-OP FOR TOTAL ANOMALOUS PULMONARY VENOUS REPAIR PERFORMED AT ANOTHER FACILITY (TERTIARY CENTER). PATIENT CODED WHILE AT HOME; CPR WAS COMMENCED AT HOME. PATIENT WAS TRANSPORTED VIA AMBULANCE. DURING CODE, ELECTRODES FAILED TO ADHERE TO PATIENT'S SKIN. NURSE DESCRIBED PATIENT SKIN AS "STRANGE - ALMOST SLIMY". NURSE IMPROVISED BY TAPING ELECTRODE TO SKIN. MANUFACTURER RESPONSE FOR PEDIATRIC MONITORING ELECTRODE, RED DOT ELECTRODE: MANUFACTURER PRODUCT COMPLAINT LINE WAS NOTIFIED. TECHNICAL PERSON WOULD CALL BACK.
Conmed Corporation/Electrocardiograph Electrode Lot: 0710111 IT WAS REPORTED THAT "A CHILD HAD A HOLTER MONITOR ON FOR LESS THAN 48 HOURS. USING 1650-005, AT 4 LOCATIONS, BLISTERS DEVELOPED, NOW THEY APPEAR TO BE SCAR TISSUE. CHILD IS TO BE SEEN BY A DERMATOLOGIST."
Tyco Healthcare Group LP/Electrocardiograph Electrode Device Identifiers Unknown/Not Available FLUID FILLED BLISTERS NOTED ON RIGHT CHEST UNDER EKG ELECTRODE -KENDALL PUPPY DOG 5 LEAD PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODE-. ELECTRODES PLACED ON CHILD IN 2008 FOR OPEN HEART SURGERY. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: NO.
Tyco Healthcare Group LP/Electrocardiograph Electrode Device Identifiers Unknown/Not Available DT FOUND TO HAVE DEVELOPED BLISTERS UNDERNEATH 2 OF THE FIVE EKG LEADS -KENDALL PUPPYDOG 5 LEAD PREWIRED NEONATAL/PEDIATRIC RADIOLUCENT ELECTRODES-; RIGHT UPPER CHEST UNDER WHITE LEAD AND LEFT MIDCLAVICULAR LOWER TRUNK UNDER BROWN LEAD. MD NOTIFIED AND AT BEDSIDE TO ASSESS PT WITH CHARGE NURSE. PICTURE TAKEN OF BLISTERS AND DOCUMENTED. LEADS WERE REMOVED AND REPLACED WITH NEOTRODE LEADS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CARDIAC MONITORING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.



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