MAUDE Adverse Event Report: CARDINAL HEALTH CADENCE HEARTSTREAM ADULT RTS; PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)

Model Number 22660R

Device Problem Peeled/Delaminated (1454)

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

Event Date 12/02/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that half of the conductive jelly appears to stick to the disposable part instead of on the patient.Additional information provided stated that there was no patient harm or delay.This issue occurred during a patient case and was noticed prior to putting the pads on the patient; the product was not used.The customer then opened everything they had left in stock.These were defib pads that the customer happened to find in their warehouse after their current supplier had a backorder.The defib pads were last ordered from us in 2019.The customer stated that they knew the product was past the expiration date (august 2020) but since they did not have any other option, they tried to use them until they noticed that the jelly was not working/was broken.

Manufacturer Narrative

The device history record (dhr) for product code 22660r, production lot number 822922x, was reviewed for any problems and disparities.A dhr review provides information that could reveal any unusual circumstances that may have led to the issues at hand.Lot 822922x was manufactured in august 2018 with a product use by date of 2020-08-21.As stated in the reported description, this product has been expired for over a year.All process parameters, product, raw materials, and sub-assembly components met the required acceptance criteria to completely satisfy the manufacturing requirements per the product specification.No adverse conditions, special circumstances, or events were documented that may have led to the gel delamination and/or skin irritation.In addition, the dhrs were reviewed for the hydrogel body subassembly that were used.The dhrs for the hydrogel body sub-assemblies met all acceptance criteria.The hydrogel body sub-assembly lots were manufactured in june 2018.Raw material records were reviewed as well and all acceptance criteria was met.The uv dosage outputs for curing the hydrogel bodies were within the proper range.The conductive silver/silver chloride ink and gel batch mix sheets were also reviewed.All components and mix time were within tolerance.During the production of hydrogel bodies, four corner peel testing per lab specification, is performed to simulate the removal of the electrode release liner by a clinician prior to delivering therapy (corners of gel body are lifted from the liner to evaluate for release of gel from the substrate).The product met the testing requirements.The event described is commonly referred to gel delamination.Gel delamination occurs when the gel-to-release liner bond strength is greater than the cohesive strength of the gel or greater than the gel-to-substrate bond strength.Such an inequity in bond strength can cause the gel to peel from the substrate and/or tear.Delamination is categorized as follows: an aesthetic delamination defect is characterized by a permanent separation of the hydrogel from the substrate, exposing the underlying carbon vinyl with little (i.E.Area less than 1/8 inch x 1/8 inch) or no hydrogel remains on the release liner.Also, no silver/silver chloride ink is exposed.Aesthetic delamination defects will not significantly affect electrode function but may displease the clinician.Functional delamination is a permanent separation of the hydrogel from the substrate such that the silver/silver chloride ink remains exposed.Additionally, per our procedure there shall be no less than 55% hydrogel remaining on the adult electrode when the release liner is removed from the electrode.There shall be no less than 78% hydrogel remaining on the adult electrode, when the area of separation includes the area of underlying conductive mat.With loss of the hydrogel no more than the percentages as defined above the electrodes retain functionally essential performance; however the reduction in the hydrogel area with the silver/silver chloride ink being exposed may cause an increase in current density across the remaining gel area.This increases the potential for skin irritation and burns.Complaint samples received both as photos and physical samples.Photos of the lot verify the product was manufactured in 2018 and expired in august of 2020.Photos of the electrodes show there is gel delamination throughout the product.Pouches received both open/unsealed and sealed product.Visual inspection showed some of the samples delaminated during the removal of the liner.The labeling on the pouches also verified the product had expired in august of 2020 (2020-08-21 more than a year prior to the reported date).Production retains could not be inspected; they were disposed 3 months after the expiration of the product.Based on the complaint description provided and the investigation, it is not possible to determine if this is manufacturing related or if related to the product expiration.Additionally, gel delamination is possible if the defib electrodes are not properly stored.As indicated on the product packaging proper storage and usage of the electrodes is critical to the performance of the gel.The electrodes should be stored in their sealed protective pouch in a cool, dry place and out of direct sunlight.Do not open package until ready for use.Do not bend, fold, or puncture the packaging.Improper storage conditions and/or handling of the product may compromise gel properties prior to the expiration.From a corrective or preventative action perspective no corrective or preventative actions are necessary.It should be noted the manufacturing facility has implemented the use of an improved uv curing system.The gel bodies have been validated as a process improvement.The variable power output allows more flexibility to dial in the uv intensity while mitigating excess heat generation in the oven and improving gel release from liner performance throughout the life of the product and reducing the probability of gel delamination.We will continue to trend this issue for future occurrences as part of the complaint review process.

• Brand Name: CADENCE HEARTSTREAM ADULT RTS
• Type of Device: PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)
• Manufacturer (Section D): CARDINAL HEALTH; 2 ludlow parkway; chicopee MA 01022
• 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: 13006426
• MDR Text Key: 282497746
• Report Number: 1219103-2021-00342
• Device Sequence Number: 1
• Product Code: DRO
• UDI-Device Identifier: 20884527022349
• UDI-Public: 20884527022349
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/21/2020
• Device Model Number: 22660R
• Device Catalogue Number: 22660R
• Device Lot Number: 822922X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2021
• 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