AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR 10031#AVALON ELITE 31F, 31CM 701063538

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-25 for AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR 10031#AVALON ELITE 31F, 31CM 701063538 manufactured by Maquet Cardiopulmonary Gmbh.

Event Text Entries

[180708134] The sample is not available for return.
Patient Sequence No: 1, Text Type: N, H10


[180708135] This patient is a (b)(6) year old male with influenza a, the customer put him on support with a 31 french cannula. This cannula was placed using xray and ultrasound. The customer reported issues with the cannula being positional despite perfect placement. Further information received on 2020-02-06: "the (b)(6) year old male? S cannula is now flowing without issues. There was a tee performed yesterday which showed the cannula is in perfect placement. All the extra supports i had placed on the cannula and circuit were removed the patient? S head was turned side to side and the cannula did not move. Not sure why there were issues the first two days but now? All resolved.? The customer stated on (b)(6) 2020:? Our patient expired early this morning and i was not able to retrieve the cannula.? (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008355164-2020-00010
MDR Report Key9749560
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2020-02-03
Date Facility Aware2020-02-03
Report Date2020-02-25
Date Reported to FDA2020-02-25
Date Reported to Mfgr2020-02-25
Date Added to Maude2020-02-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-02-25
Model Number10031#AVALON ELITE 31F, 31CM
Catalog Number701063538
Lot Number205257
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerMAQUET CARDIOPULMONARY GMBH
Manufacturer AddressNEUE ROTTENBURGER STRASSE 37 HECHINGEN US


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-02-25

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