MAUDE Adverse Event Report: OWENS & MINOR INSTANT COLD PACKS

Model Number CWP903

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Edema (1820); Erythema (1840); Fever (1858); Hypovolemic Shock (1917); Respiratory Failure (2484); Alteration In Body Temperature (2682); Partial thickness (Second Degree) Burn (2694); No Code Available (3191)

Event Date 05/06/2016

Event Type  malfunction  

Event Description

This event involves a critically ill male toddler who sustained second degree frostbite as a result of cold therapy for temperature reduction while in the pediatric intensive care unit.A male toddler was transferred emergently by med flight from an osh in an acute crisis with severe abdominal pain, respiratory failure, hypovolemic shock and concern for suspected torsion of the large bowel.On arrival to picu was sedated and receiving dopamine 10 mcg/kg/min.Central line was placed and exam was notable for rigid abdomen, increase capillary refill and dusky skin tone.The patient was promptly taken to the operating room for an exploratory laparotomy with segmental colectomy with double barrel colostomy.The 2 hour procedure was performed without complication and the patient was transferred back to the picu.On admission, the patient was mottled, pale, and cool to touch.Dopamine increased to 15 mcg/kg/min to maintain map in 60's.Overnight, the patient continued to spike fevers but the caregivers were able to wean off the dopamine by 0300.He was started on acetaminophen 150mg iv with the first picu dose given at 2313 and was continued every 6 hours for 4 additional doses.Over the next 24 hours, the patient remained febrile, and the patient's axillary temperature reached a tmax of 39.8 degrees celsius (103.64 degrees fahrenheit) with no response to the iv acetaminophen.Cooling therapy was initiated at 2000 using multiple instant cold packs (medichoice instant cold compress) that were covered with a blanket and placed under the patient.During the night, the patient was repositioned frequently and the packs were replaced once at 0300 with a second temperature spike to 39.6 degrees celsius.The patient was described as having generalized global edema that was treated with iv lasix.The patient remained febrile and was given a cool bath following the temperature spike to 39.6 degrees celsius in an effort to bring down his temperature.That afternoon a large blister was noted on the upper left side on his back, in the fold of his neck and there was an erythematic patch under his left ear.The blistered area on the patient's back opened on the night shift.The physician was notified and evaluated the site.It was cleaned with sterile water and mupirocin ointment was applied.The next day the skin lesion extended itself.Xeroform and bactroban were applied to the wound site with mepilex dressing to back and neck area to decrease friction caused by the patient moving.A dermatology consult was requested, and the injury was attributed primarily to the use of cold therapy.(a review by the burn service also identified the patient's lesion as second degree frostbite).The patient remained hospitalized for the treatment of his underlying condition and was discharged home with services several weeks later.The patient continues to improve and follow up with pediatric surgery as well as dermatology who are evaluating the status of the healing and examining other possible skin sensitivities.

• Brand Name: INSTANT COLD PACKS
• Type of Device: COLD PACK
• Manufacturer (Section D): OWENS & MINOR; 9120 lockwood blvd; mechanicsville VA 23116
• MDR Report Key: 5842692
• MDR Text Key: 51018852
• Report Number: 5842692
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CWP903
• Device Catalogue Number: CWP903
• Other Device ID Number: JUNIOR 5 × 7 INCH
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/25/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS
• Patient Outcome(s): Other
• Patient Age: 2 YR