IMPELLA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for IMPELLA manufactured by Abiomed, Inc..

Event Text Entries

[123547966] Just before 0400, the rn and pca had completed a patient bath post bowel movement. While cleaning the patient, the patient was moving her legs and squirming but the staff was able to keep her on her side for a sheet change. There were no observed incidents involving the impella catheter at this time. Patient was returned supine with pillow under right side. The rn began a sterile dressing change at about 0405. While the rn was taking down the old dressing, the impella controller alarmed "air in line". The rn observed a kink in the tubing and the alarm was resolved. At approximately 0409, the controller alarmed "purge system open". At this time, the rn assessed the tubing again and noticed purge fluid leaking from the translucent yellow connection which was connected by the blue disc of the glucose filter module. The rn manager was called to the bedside and the issue was assessed. Noticed that the male portion near the translucent yellow connection appeared snapped and a piece of the clear connector was lodged in the female portion near the blue disc. Abiomed support line called and spoke with rep who instructed us to cut off the glucose filter and connect the dark yellow to a blunt tip 18-20 gauge needle. We cut the one inch line between the 0. 2 micron filter and inserted the needle into the remaining portion of the one inch tubing. Impella flow, purge flow, and purge pressure returned to the pre-incident level. Per abiomed rep, he will report it to the team and they will follow up today.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7960316
MDR Report Key7960316
Date Received2018-10-12
Date of Report2018-09-28
Date of Event2018-05-04
Report Date2018-09-28
Date Reported to FDA2018-09-28
Date Reported to Mfgr2018-10-12
Date Added to Maude2018-10-12
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA
Generic NameTEMPORARY CARDIAC SUPPORT BLOOD PUMP
Product CodePBL
Date Received2018-10-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR. DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-12

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