Summary of MedSun Reports Describing Adverse Events With Hot Disposable Packs
MedSun: Newsletter #44, January 2010

A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces. [1]

Over the past 2 years, MedSun has received 12 adverse event reports associated with the hot disposable pack device manufactured by 5 different manufacturers: Hospital Marketing Services Co., Inc. (4), Cardinal Health (4), Kimberly-Clark Corp. (2), Cooper Surgical, Inc. (1), Medline Industries Holdings, L.P. (1). The reports were submitted by 8 hospitals between July 2007 and July 2009.


The reported device problems were :

• Excessive heat produced (4)
• Device burst (4)
• Tape adhered excessively (2)
• Device leakage (1)
• Human factors: did not apply sleeve to pack (1)

No reports involved a patient death. The patient injuries listed below were reported in 11 of these 12 reports.

• Nurse sprayed with contents of pack (4)
• Second degree burn (2)
• Skin tears from tape (2)
• Blisters (2)
• Unspecified level burn (1)

Of the reports that listed patient age, none had a patient age listed as less than 21 years and 9 had a patient age listed as greater than 21 years. Of the reports that listed patient gender, a total of 6 reports involved female patients and a total of 3 reports involved male patients.

The below MedSun reports contributed to FDA awareness of the device problems.


Adverse Event Reports
DeviceDevice Identifiers (model, catalogue number, lot) Event Description
Hospital Marketing Services Co., Inc/Instant warm pack--large None/V6001-043/6378-2 The patient was a difficult IV start. Staff applied two warm packs, both with sleeves, to the patient's bilateral forearms. This was done in an attempt to enhance vasodilation & facilitate ease of IV insertion. The patient complained that the sites were warm and beginning to hurt. When the packs were removed, a fluid filled blister measuring 2cm x 2cm was noted on the left posterior forearm and another fluid filled blister measuring 1cm long x 0.5cm wide was on the right posterior forearm. The RN notified the physician. Both sites were cleaned and dressed with a dressing. There were no changes to the patient's plan of care. An IV was started in another location.
Hospital Marketing Services Co, Inc./ Instant Warm Pack None/V6001-047/None A heat pack was applied, while in an appropriate sleeve, to the patient's neck for neck discomfort. Approximately 2.5 hours later, the patient rang out for the nurse to report a blister on her neck.
Hospital Marketing Sercies,Co., Inc/Instant Warm Pack None/V6001-047/None Patient had first degree burns on abdomen. Apparantly this was from a heat pack on the day of discharge. Six days later the patient was noted to have second degree burns to their abdomen (with eschar). Oral antibiotics were started and silvadene cream and clinic appts were initiated.
Hospital Marketing Services Co., Inc/NovaPlus Instant Warm Pack None/V6001-043/None Patient reported to RN that she was burned from the warm pack that was placed on her left arm prior to an IV start. RN noted the area was red with slight elevation, but no blistering. Patient complained of discomfort. MD notified--no change in management plan. No medications required to treat reddened area. RN noted that the warm pack had been applied directly to the skin and that the hot pack cover had not been applied. This heat pack is a relatively new product to our facility. The previous product did not require a cover or sleeve--this new product does. Staff applied the heat pack without the sleeve, although the packaging clearly indicates that a towel or soft cover should be wrapped around the heat pack before application.
Cooper Surgical/Prism Warm Gel Instant Heat Pack None/20420/None The patient was discharged from the hospital via ambulance to a skilled nursing facility. Upon arrival at the SNF, the patient was found to have what appears to be a second degree burn on her left hand, palm, wrist, and between some of her fingers. There also is a burn on the inner aspect of her right wrist. No such assessment findings were present while the patient was at the hospital before she was discharged. The receiving SNF noted that the patient's left lower arm/hand had a Prism heat pack with a gauze roll holding it in place. The patient's husband has retained the device. Per the husband, the heat pack is not broken and is not leaking.
Medline Industries, Inc./ Accu-Therm None/MDS138005/8079 We have had reports of hot/cold packs exploding. People using these packs are usually moving quickly, trying to take care of patients. It doesn't seem that it was an extreme amount of force that was used to cause the pack to burst. Medline is coming in to investigate these reports and is providing me a formal response. There had been reports of the hot pack being too hot and in some cases bursting. This is the pack that burst on an employee. These packs were pulled off our shelves and pulled from stock. The Medline Account Manager was involved the return process. A member intake specialist at Urgency Care had an instant ice pack explode upon activation.
Cardinal Health/Jack Frost None/30104/V8E135 Staff RN was preparing an Instant Insulated Hot Pack for use on the patient. Following the package instructions the nurse squeezed the package and the package exploded through the top seal and sprayed the nurse in the face and upper body with the liquid contents of the heat pack.
Cardinal Health/Instant Hot Pack Medium None/11450-040/V8E041 When opening a heat pack the heat pack burst open sending it's contents all over the RN, Pyxis and floor.
Cardinal Health Medical Products and Services/Instant Cold Pack, Large None/11440-012/V7H101 The Instant Cold Pack was activated per instructions on package. The staff member felt liquid on her left hand. There was a small amount of clear fluid on the back of her hand. It appeared the package was seeping liquid from a corner. Package design requires pressure on each side, which "pops", then the chemical reaction becomes cold. A few months ago, the same thing happened when another staff member was activating a different cold pack. The remaining packs from that lot number were pulled, and the problem was reported to the regional risk office. Manufacturer response for Chemical Ice Pack, Instant Cold Pack, Large. The sales representitive came and evaluated the device. He then said he was going to take the information back to his quality department for evaluation. We have not received any work of the testing.
Cardinal Health Medical Products and Services/None None/11450-040/None While starting an IV, RN squeezed a hot pack, which exploded onto side of RN's face and upper body. Contents became warm but did not burn. RN showered, and sustained no injury.
Kimberly-Clark Corporation/ Energy Transfer Pad None/None/392105 Kimberly Clark warming pads used on patient during surgery. Side tapes (on pad) were removed gently from the patient's sides. There was redness and weeping on both sides where the tape had been. Nursing informed of injury. Per medical record, stage II skin tears to chest laterally (auxiliary to hips).
Kimberly-Clark Corporation/Energy Transfer Pad None/00315-05Z/386232 A 10 cm X 1 cm red mark, skin tear to left lateral chest involving Kimberly Clark disposable warming pads.

Additional Information:

[1] Food and Drug Administration. (2008). Code of Federal Regulations Title 21.Retrieved July 28, 2009. Website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=890.5710


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