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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110 JCX Back to Search Results
Catalog Number PMX110
Device Problems Aspiration Issue; Device Operates Differently Than Expected; No Pressure
Event Date 12/28/2017
Event Type  Malfunction  
Manufacturer Narrative

Results: the regulator knob tubing of the penumbra system aspiration pump max 110v (pump max) was kinked. Conclusions: evaluation of the returned device revealed that the pump max gauge or the calibrated gauge would not decrease or increase when the regulator knob was adjusted. The pump max housing was opened by the penumbra investigator and it was observed that the regulator knob tubing was kinked. This damage likely occurred due to overtightening of the regulator knob while adjusting the vacuum pressure. The kink in the tubing was removed by the penumbra investigator and the pump max was powered on. The gauge on the pump and the calibrated gauge were able to be increased and decreased using the regulator knob. The kink in the tubing likely prevented the pump max vacuum pressure from being adjusted during the preparation for the procedure. The pump max was plugged in and powered on and the vacuum gauge did not increase or decrease using the regulator knob while attempting to be adjusted during the functional test. Penumbra pumps are 100% functionally tested during coming inspection by quality. 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 technician noticed that the penumbra system aspiration pump max 110 (pump max) was unable to produce vacuum, despite the regulator gauge being turned up and the gauge showing full power. The inability of the pump max to produce vacuum was noticed prior to use, and therefore the pump max was not used in the procedure. The procedure was therefore completed using a new pump max.

 
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Brand NamePENUMBRA SYSTEM ASPIRATION PUMP MAX 110
Type of DeviceJCX
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer (Section G)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key7220366
Report Number3005168196-2018-00209
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/25/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberPMX110
Device LOT NumberF15336-11
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/09/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/27/2015
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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