FDA.reportPublic FDA data

MAUDE MDR 4878281

MDR report key
4878281
Report number
3034520-2015-00001
Event key
0
Event type
3
Date of event
2015-01-21
Date received
2015-06-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GEORGE BIGGINS
Address
9800 EVERGREEN WAY EVERETT WA 98204 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RENU MEDICAL REPROCESSED MASIMO LNCSOXIMETER, REPROCESSEDRENU MEDICAL, INC.NLFLNCS1859R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-06-260

Event Narratives#

D

Patient 1

THIS REPORT IS BEING FILED TO FOLLOW-UP ON AN ISSUE REPORTED IN MEDWATCH REPORT (B)(4). THIS REPORT INDICATED THAT A PATIENT WAS NOTICE TO HAVE A PUS FILLED BLISTER ON A FINGER ON WHICH AN SPO2 SENSOR WAS PLACED DURING A COLONOSCOPY. (THIS WAS LATER CLARIFIED BY THE FACILITY TO INDICATE THAT THE PATIENT REPORTED THE ISSUE TO THE HOSPITAL IN A POST-OP VISIT). THIS ISSUE WAS REPORTED DUE TO " CONCERN REGARDING (B)(6) AND DUE TO A HISTORY OF OTHER POSSIBLE PROBLEMS WITH SPO2 SENSORS.

N

Patient 1

ALTHOUGH IT IS UNCERTAIN THAT THIS ISSUE REPRESENTS A REPORTABLE INCIDENT INVOLVING A DEVICE REPROCESSED BY RENU MEDICAL, IT IS BEING REPORTED TO ADDRESS INFORMATION SUBMITTED IN THE FACILITY REPORT. RESULTS OF INVESTIGATION: NO DEVICE WAS ASSESSED BY THE REPORTER. IT IS UNCLEAR WHETHER THE ISSUE INVOLVED A SENSOR REPROCESSED BY RENU MEDICAL. DURING FOLLOW-UP WITH THE REPORTER HE INDICATED THAT BASED ON THE ASSUMPTION THAT RENU MEDICAL WAS THE SOLE VENDOR SUPPLYING SENSORS TO THE FACILITY (B)(4). IT IS IMPLAUSIBLE THAT THE USE OF A SENSOR WOULD RESULT IN THE ISSUE REPORTED. SPO2 SENSORS DO NOT TRANSMIT EITHER HEAT OR IONIZING ENERGY. MATERIALS USED IN THE ADHESIVE ARE QUALIFIED THROUGH BIOCOMPATIBILITY TESTING. NO CHEMICAL DISINFECTANTS ARE USED IN THE REPROCESSING OF THE SENSORS. CLINICAL REVIEW CONCLUDES THAT ALTHOUGH THE CUSTOMER LATER ALLEGED TO THE FACILITY THAT SHE SUBSEQUENTLY DEVELOPED A (B)(6) INFECTION AFTER "POPPING THE BLISTER," THE INFECTION WOULD HAVE BEEN THE RESULT OF A POST HOSPITAL INFECTION AND NOT ASSOCIATED WITH THE USE OF AN SPO2 SENSOR. THE REPORTER SUBSEQUENTLY CLARIFIED THAT THERE IS NOT A HISTORY OF SPO2 PROBLEMS (EITHER NEW OR REPROCESSED) AT THE FACILITY.