MAUDE Adverse Event Report: CARDINAL HEALTH WARMERS, INFANT HEEL W/TABS; INFANT HEEL WARMER (CHEMICAL HEAT PACK)

Model Number MH00002T

Device Problem Temperature Problem (3022)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that they have not ordered this product since 2020 and per the clinical manager, they found a box and added the product to their shelf in the supply room.On activation, the product became very hot.The reporter tried it and it was way above the expected temperature.They do not know how the product was stored.They pulled all the product and validated that there wasn't any remaining in the nicu or pediatrics.The product was not used on an infant as the nurse identified the issue open activation.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.There were no non-conformances noted.The product was manufactured in january 2016.One box of physical samples were received at the manufacturing site for evaluation.Visual inspection of the samples did not show any visible issues.Inspection of the product after activation showed the product got very hot.The reported condition was confirmed.Two thermometers were used to test the product and each sample activated reached over 110 degrees which is over the acceptable tolerance.From a root cause analysis perspective, it is not possible to determine the cause as possible causes for temperature issues are incorrect amount of sodium acetate, incorrect water pre-heat temperature, incorrect water quantity, mixing time error, or a speed setting error but none of these issues were noted during production as they would have resulted in a non-conformance report being issued.The heal warmer pouches were weighed and were within the acceptable tolerance per procedure of 45-55 grams.A corrective action is not applicable at this time as the equipment has been decommissioned.However, we will continue to trend this issue for future occurrences as part of the complaint review process.This complaint will be used for tracking and trending purposes.

• Brand Name: WARMERS, INFANT HEEL W/TABS
• Type of Device: INFANT HEEL WARMER (CHEMICAL HEAT PACK)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15156310
• MDR Text Key: 304957472
• Report Number: 1219103-2022-00366
• Device Sequence Number: 1
• Product Code: MPO
• UDI-Device Identifier: 30884527004632
• UDI-Public: 30884527004632
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

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: Health Professional
• Device Model Number: MH00002T
• Device Catalogue Number: MH00002T
• Device Lot Number: 602906X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 07/29/2022
• Supplement Dates FDA Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1