MAUDE Adverse Event Report: CARDINAL HEALTH 230 MEDI-TRACE 30 PK 600 CA; ELECTRODE, ELECTROCARDIOGRAPH

Model Number 31078135

Device Problem Failure to Analyze Signal (1539)

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

Event Date 02/16/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during use, an ecg was requested.The electrodes were placed on the patient in the correct places and double checked using very careful anatomical landmarks.Due to the malfunction of the electrodes, it was possible to observe several artifacts during the reading of the ecg which made the reading incomprehensible.Sometimes, there was also an absence of current flow in the electrodes which created an asystole, even if the patient was in perfect health.A second ecg machine was tried, and the same malfunction was observed.These 2 ecgs have been verified by a biomed tech in the last few months.The same test with a different lot was done and no problems were detected with the new lot.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations and no non-conformances initiated with this lot code.There were no samples submitted with this complaint; however, the complaint will be reopened if a sample is later received.Because no sample was returned with this complaint, no physical product examination was possible to perform an examination/tests and confirm the function of the electrodes; therefore, the reported condition could not be confirmed.Current manufacturing practices require production to be sampled and inspected through a series of functional and visual testing based on valid aql sampling plans to ensure product quality.Without a sample that displays the reported condition or a sample in which the reported condition can be duplicated, the root cause cannot be positively attributed to a product design or manufacturing problem.Had a sample been received, it would have been evaluated against the established product requirements.Since this complaint is unconfirmed and no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

Manufacturer Narrative

Section h6: investigation findings - initially selected as: 213 and should have been coded as 170.Section h6: investigation conclusions - initially selected as: 67 and should have been coded as 25.Section h10: additional manufacturer narrative updated statement is: the device was received for evaluation and the reported condition has been confirmed.A corrective and preventive action has been initiated to address the reported issue.

Manufacturer Narrative

There were 93 samples returned, 32 samples (279 electrodes).Using acceptable quality level (aql) s2, 0.65 = 32 samples were randomly pulled from the pouches and were visually examined and there were no abnormalities identified.The same 32 were then subjected to texture analyzer testing which measures the adhesive performance of the hydrogel.All visual and functional testing was performed.The specification for the adhesive performance is a minimum travel of 6.027mm ¿ the results for the 32 electrodes was a minimum of 7.145 and a maximum of 13.414, which is within specification.Additionally, it is worth noting that as part of in-process critical to quality testing, finished product is sampled across the length of the lot manufacture.These samples are also subjected to texture analyzer testing.The average travel width for this order was 9.720, which is within specification.; therefore, the reported condition of adhesion issues could not be confirmed.The most probable root cause for adhesion issues could be related to the performance of the supplier hydrogel.The hydrogel used in 40000034 lot 118304ga was subjected to hydrogel texture analyzer travel width results from the supplier and are 8.683 mm, which is within specification.Controls are in place at both the raw material and finished product manufacturing facilities that monitor the adhesive properties of the hydrogel to ensure it meets the established product requirements.A possible root cause of poor electrode adhesion includes skin preparation practices prior to electrode application.It is worth noting that paying strict attention to skin prep procedures and ensuring that the application site is cleaned with a warm soapy solution and dried prior to placing the electrode will help to ensure good adhesion.A second root cause is the possibility of the electrodes being repositioned to other locations.This can cause the adhesion properties to be less effective when using on the patient.There have been no design changes to this product within the past year that would contribute to any increased probability of low adhesion.Since this complaint is unconfirmed and no complaint trend exists and a specific root cause for the occurrence cannot be identified, no corrective action is required at this time.This complaint will be recorded for tracking and trending purposes.

• Brand Name: 230 MEDI-TRACE 30 PK 600 CA
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer (Section G): CARDINAL HEALTH; 215 hebert st; gananoque K7G 2 Y7; CA K7G 2Y7
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13685825
• MDR Text Key: 289978865
• Report Number: 9681860-2022-00526
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 20884527007933
• UDI-Public: 20884527007933
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 31078135
• Device Catalogue Number: 31078135
• Device Lot Number: 914514X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2022
• 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