MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEMOSPHERE INSTRUMENT (HEM1)

Model Number HEM1

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The product is expected to be returned for product evaluation; but has not yet arrived.When the findings are available a supplemental submission will be submitted.The device service history record review is pending.When the results are available a supplemental submission will submitted.The mdr submission number for the sg module involved will be submitted in a supplemental submission.

Event Description

It was reported that the hem1 instrument and swan ganz module were being used for patient monitoring.The values that were displayed did not ¿make sense¿ to the clinician; they did not correlate to the patient¿s condition.The clinician contacted edwards technical support department for help in troubleshooting over the phone.The clinician could not recall if the patient height and weight information had been entered correctly.They were advised to exchange the suspect hem1 unit and sg module and then the appropriate numbers were displayed.There was no inappropriate patient treatment provided.There was no patient harm or injury reported.

Manufacturer Narrative

The product has been returned and received for evaluation.However, the product evaluation results are not yet available.When the evaluation is completed a supplemental report will be submitted with the findings.The device service history record review is pending.When the results are available a supplemental report will be submitted.The udi number is (b)(4).The sg module involved submission number is 2015691-2019-04022.

Manufacturer Narrative

One hemosphere instrument (hem1) was returned for product evaluation.The suspect instrument was connected to a known good working swan ganz module and hemosphere oximetry cable for testing and analysis.The system verification test was performed.The co and sv02 values were within appropriate parameters.The verification test was left to run for 36 hours using the patient demographic data shown in the diagnostics logs.The co values remained within appropriate parameters during testing.An inspection of the instrument was performed and there was no physical damage identified.There was no defect found.The suspect sg module that was involved in the event, submission 2015691-2019-04022, was evaluated and found to have no defect identified.The device service history record review was completed and there was a missing j24 component identified during the manufacturing inspection.It was replaced and reworked.The unit then passed all tests and inspections.There were no related non-conformances found during manufacturing.The reported issue was not confirmed by evaluation.It could not be determined if any clinical or procedural factors may have contributed to the reported event.There is no evidence or indication that a manufacturing defect is responsible for the reported issue; therefore, no corrective action was taken.There was no inappropriate patient treatment administered.With any hemodynamic monitoring, readings can change quickly and dramatically.Clinicians are trained to evaluate the entire clinical presentation of the patient in order to make decisions.In addition, these devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEMOSPHERE INSTRUMENT (HEM1)
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 9255938
• MDR Text Key: 196578544
• Report Number: 2015691-2019-04023
• 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,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1