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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V JCX Back to Search Results
Catalog Number PMX110
Device Problems Aspiration Issue; No Pressure
Event Date 10/14/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was opened by a penumbra investigator and slight corrosion was observed on the piston crown in the outlet cylinder. Conclusions: evaluation of the returned device revealed that the pump was functional. The pump was plugged in and powered on and vacuum was generated. The pump may present difficulty turning on when under vacuum. The vacuum pressure may have to decrease prior to restarting the pump. The pump was opened by the penumbra investigator and slight corrosion was observed. The observed corrosion was likely incidental and unrelated to the reported events. Evaluation of the tubing revealed that the returned portion was functional. The tubing was flushed with fluid and air during decontamination without an issue. Since only a portion of the tubing was returned for evaluation, the root cause of the reported event could not be confirmed. Penumbra pumps are visually and functionally inspected during incoming quality inspection. Penumbra tubing is visually inspected during in-process inspection. The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns. This report is associated with mfr report number: 3005168196-2016-01605.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110v (pump max) and the indigo system aspiration tubing (tubing). During the procedure, the pump max was powered on and the green power button illuminated but the pump max was unable to create vacuum. In addition, the physician noticed that the valve on the tubing would not open. The technician then changed out the tubing for a new penumbra system aspiration tubing (new tubing) and unplugged the pump max several times. After about three minutes or so, the pump max was able to produce vacuum through the new tubing. Therefore, the procedure was completed using the same pump max and the new tubing. There was no report of an adverse effect to the patient.

 
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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 Key6096069
Report Number3005168196-2016-01604
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/14/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF07119-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/25/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/13/2014
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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