IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-26 for IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..

Event Text Entries

[185477403] Device discarded by customer. The impella cp optical pump was discarded by the customer therefore a failure analysis investigation cannot be completed.
Patient Sequence No: 1, Text Type: N, H10


[185477404] The complainant reported a (b)(6) white male patient had impella cp optical pump inserted in the left femoral artery (lfa) for acute myocardial infarction (ami)/ cardiogenic shock (cgs). Upon removal of the peel-away sheath post procedure, it was noted that the lfa site was bleeding and despite attempts to angle match the catheter and "snug" the perclose sutures around the sheath the site continued to bleed. The physician decided to remove the pump and obtain hemostasis on the lfa site with perclose. A second pump was placed due to hemodynamic instability. A central line was placed for blood/fluids to be administered. The patient was initially given two (2) units of whole blood and three (3) more units of whole blood was giving during the case.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2020-00395
MDR Report Key9887049
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-03-06
Date Facility Aware2020-03-06
Date Mfgr Received2020-03-06
Device Manufacturer Date2020-02-05
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactMR. RALPH BARISANO
Manufacturer Street22 CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal01923
Manufacturer G1ABIOMED, INC.
Manufacturer Street22 CHERRY HILL DR
Manufacturer CityDANVERS MA 01923
Manufacturer CountryUS
Manufacturer Postal Code01923
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIMPELLA CP OPTICAL PUMP
Generic NameTEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP,
Product CodeOZD
Date Received2020-03-26
Model NumberIMPELLA CP PUMP 371 SET, US
Catalog Number0048-0024
Lot Number1460151
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABIOMED, INC.
Manufacturer Address22 CHERRY HILL DR DANVERS MA 01923 US 01923


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-26

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