FDA.reportPublic FDA data

MAUDE MDR 9746279

MDR report key
9746279
Report number
8010762-2020-00082
Event key
0
Event type
3
Date of event
2019-11-12
Date received
2020-02-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 RASTATT 76437 GM
Phone
497-497-4972
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 27FRCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASSMAQUET CARDIOPULMONARY GMBHDWFELITE CATHETER701063537218747N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2401. D

Event Narratives#

N

Patient 1

THE SAMPLE WAS DISCARDED BY THE HOSPITAL.

D

Patient 1

IT WAS REPORTED THAT THE CUSTOMER HAD A PATIENT WITH RESPIRATORY FAILURE, THEY INITIALLY PUT IN A 27 FRENCH (LOT# 218747) ON (B)(6) 2019 AND IT KEPT TORQUING SO THEY CHANGED IT OUT TO A 31 FRENCH (LOT# 205257) ON (B)(6) 2019, BUT IT WAS EXTREMELY POSITIONAL ? THEY HAD TO PUT LAYERS OF 4X4S UNDER THE CANNULA TO MAINTAIN FLOW AT A STEADY LEVEL. ORIGINAL CANNULA WAS PLACED USING XRAY AND REPLACEMENT CANNULA WAS PLACED USING FLUORO. ON 2020-02-06 FURTHER INFORMATION WAS RECEIVED: THE PATIENT EXPIRED. CT OF THE HEAD SHOWED ANOXIC BRAIN INJURY. THE PATIENT?S OFFICIAL CAUSE OF DEATH FROM AUTOPSY WAS BRONCHIAL PNEUMONIA ? LUNGS WERE DESCRIBED AS COMPLETELY FIBROTIC. OXYGEN SATS WERE LOW UNLESS THE CANNULA WAS MANIPULATED. THE CANNULA NEEDED MANIPULATION EVERY FEW HOURS TO MAINTAIN OXYGEN SATS ABOVE 80. IF THE CIRCUIT TUBING CONNECTED TO THE CANNULA WAS NOT REPOSITIONED THE OXYGEN SATS WOULD DECREASE AND THE PAO2 WAS LOW AS WELL. WITH MANIPULATION OXYGEN SATS WOULD INCREASE TO THE 90?S AND PAO2 WOULD INCREASE AS WELL. ON XRAY AND ULTRASOUND THE CANNULA WAS ALWAYS IN THE CORRECT POSITION. ON THE FINAL AUTOPSY RESULT THE CANNULA WAS DETERMINED TO BE IN CORRECT PLACEMENT. NOTE: THIS COMPLAINT (27 FR. CANNULA) IS RELATED TO COMPLAINT NO (B)(4) (31 FR. CANNULA). IT CONCERNS THE SAME PATIENT BUT A DIFFERENT PRODUCT. (B)(4).