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 2020-03-18 for IMPELLA CP OPTICAL PUMP IMPELLA CP PUMP 371 SET, US 0048-0024 manufactured by Abiomed, Inc..

Event Text Entries

[183926704] Device has not been returned. The impella cp optical pump was not returned by the customer therefore a failure analysis investigation cannot be completed. If the device is received after this date, an evaluation will be performed and a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[183926705] The complainant reported a (b)(6) old white male patient had impella cp optical pump inserted in the left femoral for acute myocardial infarction (ami)/cardiogenic shock (cgs). The patient had limb ischemia despite fem and the pump was explanted. Another pump was inserted in the right axillary.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1220648-2020-00385
MDR Report Key9848467
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-18
Date of Report2020-03-18
Date of Event2020-02-17
Date Facility Aware2020-02-17
Date Mfgr Received2020-02-17
Device Manufacturer Date2020-01-08
Date Added to Maude2020-03-18
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 Received2020-03-18
Model NumberIMPELLA CP PUMP 371 SET, US
Catalog Number0048-0024
Lot Number1454868
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 2020-03-18

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