MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. PHS INFANT HEEL WARMER

Catalog Number PHS537726

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Device Emits Odor (1425); Use of Device Problem (1670)

Patient Problems Respiratory Distress (2045); Complaint, Ill-Defined (2331); Chemical Exposure (2570)

Event Date 01/15/2017

Event Type  malfunction  

Event Description

Heel warmer was squeezed to activate, popped with some contents squirting out.Majority of the contents appeared to be on the nurse's glove.She threw the warmer and gloves in trash and washed hands and forearms with soap and water.Nurse called charge nurse.Contents were reported not to be harmful as long as not mixed with cleaning chemicals (refer to another incident described below).Nurse was told to clean it with only water.She only saw few flakes of the powder on the floor, it didn't look it spread.She tried to pick it up with dry towel, then requested evs to clean.By then, no smell was there.Evs and supervisor came and they were made aware not to use any cleaning chemical in their mop.Few minutes after mopping, a faint vinegar smell was there.Nurse called a colleague to double check the smell, and it was confirmed a vinegar type smell.Charge nurse notified immediately, infant was removed from room as quick as possible.Code orange was activated for proper cleaning, all babies moved from that pod to a different area.A hepa filter was installed in the area till next morning.No more smell by then.All staff notified that going forward only activate the heel warmer in a sealed bag to avoid rupture.Previous similar incident: approximately 1 month ago; at 12:30 there was a bad smell like strong vinegar noticed in patient room in nicu.Evs had been called to clean something on the floor (which later appeared to be the residues of a broken heal warmer).Evs were asked if they are using new chemical and that was maybe the reason of the smell, the answer was no, they are still using the same products.Patient was removed immediately from the room because by then it was an unknown very strong smell, we were worried it could be toxic gas.Patient did not show any symptoms by then.Nurse supervisor was called and informed.Room was closed off and door shut to reduce effect of smell on the nearby areas.Then the patient's nurse started coughing pretty bad and she was transferred to the er (within 15 minutes of smelling it).Then it was decided to replace the whole isolette of the baby patient to be on the safe side, as it looks that smell is affecting staff.Engineering were brought to the unit after about 30 minutes to evaluate the situation, and it was confirmed that it smelled something like glue or vinegar.We were concerned about the babies and questioning whether we should evacuate.One engineer reported feeling ill after being in the room and advised to evacuate babies.Babies were evacuated immediately.The affected nurse in the er called back to report that she was under steroids and nebulizer and raising concerns about the staff and babies as well.Manufacturer response for infant heal warmer, phs (per site reporter): no response.

• Brand Name: PHS INFANT HEEL WARMER
• Type of Device: INFANT HEEL WARMER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 6269438
• MDR Text Key: 65493673
• Report Number: 6269438
• Device Sequence Number: 1
• Product Code: MPO
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: PHS537726
• Device Lot Number: CN16096B1
• Other Device ID Number: 6,318,359
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2017
• 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: NO; NO OTHER THERAPIES