MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE OXIMETRY CABLE

Model Number HEMOXSC100

Device Problems Fracture (1260); Incorrect Measurement (1383); Overheating of Device (1437); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

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 the hemosphere oximetry cable (oxsc) was being used during patient monitoring.The night charge rn stated that the cable had overheated and potentially caused damage to the swan ganz catheter that was in use.There was a fractured wire between the blue chip and the catheter.It appears it could have been damaged by tension on the catheter.They left the cable and catheter in position and continued monitoring the patient.In the morning it was noted that with any movement of the oximetry cable the values would change to the 80¿s and 90¿s, with no change in patient positioning or condition.The large change in values when there was movement of the cable was thought to be caused by the damaged cable.The rn stated that she did not look at the monitor so it is unknown if any error messages or alarms displayed.There was no inappropriate patient treatment administered.There was no patient harm or injury that occurred.The patient demographic information is not available.

Manufacturer Narrative

One hemosphere oximetry cable was returned for product evaluation.An external visual inspection was performed and there was no evidence of melting or excessive heat.It appeared the cable had been pulled with excessive force which dislodged the strain relief.Any wire fracture was not observed.The functional test was performed and it was left to run for three days using a known working hemosphere instrument (hem1) and a catheter calibration cup while slightly covered with material.The cable functioned normally and there were no error messages observed.It was noted that there was excessive epoxy with some foreign material at the fiber interface of the blue connector for the catheter.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was not confirmed by evaluation.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.Hemodynamic readings should correlate with the patient¿s clinical manifestations.In this case, the svo2 reading did correlate unless the catheter cable was moved.The clinicians continued to use the catheter and cable after this issue was discovered as accurate readings that correlated with the patient¿s clinical manifestations were observed.There were no patient complications noted in this event.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 this monthly review.No further actions will be taken at this time.The udi number is (b)(4).Refer to submission 2015691-2019-00453 for the sg catheter.

Manufacturer Narrative

Corrected data: f10, h6.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: 8305998
• MDR Text Key: 135723204
• Report Number: 2015691-2019-00387
• 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: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: HEMOXSC100
• Device Catalogue Number: HEMOXSC100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1