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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V JCX Back to Search Results
Catalog Number PMX220
Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); No Pressure (2994)
Patient Problem No Patient Involvement (2645)
Event Date 09/08/2017
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

During preparation for a thrombectomy procedure, the physician powered on the penumbra system aspiration pump max 220v (pump max) but the pump max did not produce any aspiration. Therefore, the pump max was not used on the patient and the procedure was completed using a syringe.

 
Manufacturer Narrative

Results: a pipe cleaner was inserted into the vacuum inlet on the penumbra system aspiration pump max 220 (pump max) and blood was observed inside the pump max. Therefore, the pump max was not functionally tested. Conclusions: evaluation of the returned device revealed that the pump max had blood inside. This typically occurs due to improper handling during use. If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, blood will likely enter the pump assembly, which may prevent the pump max from functioning properly. The blood inside the pump max likely prevented the pump from producing aspiration during preparation. Penumbra pumps are 100% functionally tested during incoming inspection by quality. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key6918303
MDR Text Key89472352
Report Number3005168196-2017-01705
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK122756
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/05/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF20091-23
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/08/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/29/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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