MAUDE Adverse Event Report: EDWARDS LIFESCIENCES HEMOSPHERE INSTRUMENT; HEM1

Model Number HEM1

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problem Shock (2072)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

The hem1 instrument is expected to be returned but has not yet arrived for evaluation.Once received it will be evaluated and the findings submitted in a supplemental report.The device service history record review has been completed and all manufacturing inspections passed with no non-conformances.An edwards senior director of engineering made a site visit to memorial hermann hospital where the incident occurred.The recently converted operating room was observed along with discussions with biomed.No apparent causes were identified.The clinical logs of the case were reviewed and noise was observed in the logs that are typically due to bovie usage.This implies that there is possible poor grounding of the bovie.A functional and safety check will be performed upon return of the hemosphere device for evaluation.

Event Description

It was reported that while using a large aiq cuff applied to a patients right hand middle finger and the hemosphere at the beginning of a c section case the patient immediately reported feeling a shocking sensation in her finger where clearsight was applied once the surgeon starting cutting with the use of the bovie cautery device.At that time within seconds cutting was halted and the clearsight cuff was removed from the patients finger.After checking on the status of the patient the rep assessed her finger and found no external trauma to be visibly evident.Normal color temperature movement noted no markings from diodes.The aiq cuff remained on the patient for roughly 5 to 10 minutes prior to the actual start of surgery first incision and continued to function normally with no discomfort reported by the patient until the bovie cautery was used.This was during use.

Manufacturer Narrative

One hemosphere instrument was returned csm 16802554, pc2k 600101035534, hrs 600104067265, a power cord, and a cuff.These were all connected to the hem1 except the cuff because it is expired.The connected hrs successfully zeroed and was able to acquire a normal waveform and bp readings on both cuff ports using a finger/cuff simulator.The hem1 monitor connected to and recognized a swan ganz module on module ports 1 and 2 and was also able to connect to and recognize an oximetry cable on smart cable ports 1 and 2.No error messages were observed.No damage was found.The hem1 and hemcsm10 passed electrical safety test.A visual inspection was done on the cuff and a hole was found in the plastic that covers the electrical components.This is an observation only and it can't be confirmed to be related to the rfr.

• Brand Name: HEMOSPHERE INSTRUMENT
• Type of Device: HEM1
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; one edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 15633429
• MDR Text Key: 302598396
• Report Number: 2015691-2022-08688
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 00690103197006
• UDI-Public: (01)00690103197006(11)210228
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEM1
• Device Catalogue Number: HEM1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Weight: 90 KG