MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE

Model Number HEMOXSC100

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation yet.Upon receipt of the device an evaluation will be completed and the results will be submitted in a supplemental submission.The device service history record review is pending and once the results are available they will be submitted in a supplemental submission.

Event Description

It was reported that there were inaccurate sv02 readings during use with a hemosphere oximetry cable.The sv02 reading fluctuated from 86 down to 42 ¿ 50, then to 6 and no reading and then to 36.The numbers varied with no consistent reading.There were no error messages noted.The patient was stable with no change in patient treatment.The suspect oximetry cable was replaced for a different cable, using the same monitoring equipment and accessories, then the readings were in the high 80¿s and consistent.There was no inappropriate patient treatment administered.The patient demographic information has been requested.There was no patient harm or injury.

Manufacturer Narrative

One hemosphere oximetry cable was received for product evaluation.The suspect oximetry cable was externally inspected and it was found that the two pieces of the housing were not seated completely tight together.It was consistent with one of the threads/pems was damaged in the field and would not allow a good fit.Further internal inspection found evidence of liquid ingress residue on the cable¿s controller board.The ifu includes a warning that instructs the user ¿do not allow any liquid to come in contact with the power connector.[or] allow any liquid to penetrate connectors or the openings in the case.¿ the facility will be contacted regarding the ifu warning and the edwards clinical field representative has contacted them regarding the issue.There is no indication that a manufacturing defect contributed to the failure.The reported event was confirmed by evaluation.The root cause is consistent with liquid ingress and customer mishandling.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis and any excursions above the control limits are assessed and documented as part of the monthly review.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The udi is (b)(4).

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: HEMOSPHERE OXIMETRY CABLE
• Type of Device: HEMOSPHERE OXIMETRY CABLE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8781235
• MDR Text Key: 150988631
• Report Number: 2015691-2019-02541
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2019

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 Expiration Date: 03/04/2021
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 07/16/2019; 07/23/2020
• Supplement Dates FDA Received: 08/08/2019; 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1