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 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

The product has not been received for evaluation.Once the product is returned and evaluated a supplemental report will be submitted with the evaluation findings.The device service history record review has not been completed and is pending.Once the results are available a supplemental report will be submitted with the findings.

Event Description

It was reported that during patient monitoring with the hem1 instrument that there was a discrepancy with the cco reading.The cco displayed as 1.3 and the tee was 3.8.The physician believed the tee was more accurate.They exchanged for a different monitor and it provided the 3.8 cco reading.They stated that they entered the patient data correctly, but they were unable to confirm.The facility was contacted, but no further information is available.There was no inappropriate patient treatment administered.There was no patient harm or injury.The patient demographic information has been requested and unable to be obtained.

Manufacturer Narrative

The hem1 instrument has not arrived for evaluation after several attempts were made to the facility to request return of the product.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.Edwards is unable to confirm or negate the customer¿s experience without the return of the suspect device.The root cause of the reported issue is indeterminable as the product was not evaluated.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.It is unknown if user or procedural factors contributed to the stated 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 the monthly review.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The udi is (b)(4).

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: 9167519
• MDR Text Key: 194629697
• Report Number: 2015691-2019-03711
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1