• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problem No Pressure
Event Date 07/12/2018
Event Type  Malfunction  
Manufacturer Narrative

Results: a pipe cleaner was inserted into the vacuum inlet and revealed blood inside the pump max. The device housing was opened by the penumbra investigator and dried blood was found on the inside of the device housing and vacuum pump. Conclusions: evaluation of the returned pump max revealed blood inside the pump max vacuum assembly. This is likely a result of incorrectly connecting the aspiration tubing directly to the vacuum inlet rather than the canister supplied by penumbra. This would allow blood to enter the vacuum assembly. If fluid is aspirated into the pump max, it will likely prevent the pump from functioning properly. Functional testing was performed and confirmed that the vacuum pump was unable to power on and unable to produce sufficient vacuum pressure. Penumbra pumps are 100% visually inspected and functionally tested during incoming quality inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

 
Event Description

During preparation for a thrombectomy procedure, the hospital staff noticed that the motor of the penumbra system aspiration pump max 110 (pump max) did not produce any sound. The hospital staff checked the power cable connection and turned the pump max on and off multiple times; however, the pump max did not work at all. The issue with the pump max was found prior to use and therefore the pump max was not used in the procedure. The procedure was completed using another suction equipment.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
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 Key7791836
Report Number3005168196-2018-01612
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation
Type of Report Initial
Report Date 01/01/2005,07/18/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received08/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX110
Device LOT NumberF16091-06
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report TO Manufacturer01/10/2005
Date Manufacturer Received07/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/14/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-