AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 27FR 701063537

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, 27FR 701063537 manufactured by Maquet Cardiopulmonary Gmbh.

Event Text Entries

[180707860] The sample was discarded by the hospital.
Patient Sequence No: 1, Text Type: N, H10


[180707861] 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).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008355164-2020-00008
MDR Report Key9749529
Date Received2020-02-25
Date of Report2020-02-25
Date of Event2019-11-12
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, 27FR
Generic NameCATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
Product CodeDWF
Date Received2020-02-25
Catalog Number701063537
Lot Number218747
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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