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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 Failure to Power Up; Device Stops Intermittently; Device Handling Problem
Event Date 07/11/2016
Event Type  Malfunction  
Manufacturer Narrative

Results: there was no visible damage to the exterior of the penumbra system aspiration pump max 110v (pump max). Conclusions: evaluation of the returned device revealed that the pump max was functional. The pump max was plugged in and powered on and generated vacuum. If the pump max is used to generate vacuum and then turned off, it may have to return to equilibrium with atmospheric pressure before it can generate vacuum again. It is likely that initial attempts to turn the pump max on that were reported as unsuccessful caused the pump max to generate vacuum. Additional immediate attempts to turn the pump max on were likely unsuccessful due to the pump max being under vacuum. It is likely that the time it took to troubleshoot the pump max by the hospital staff allowed the pump max vacuum pressure to return to equilibrium with atmospheric pressure, after which it was able to be successfully switched on. Penumbra pumps are 100% 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

The patient was undergoing a thrombectomy procedure in the inferior vena cava (ivc) using a penumbra system aspiration pump max 110v (pump max). During the procedure, after the pump max was successfully used for the first pass, the nurse made three attempts to turn the pump max on for the second pass but did not completely depress the "on" button on any of the attempts. Therefore, on each of the three attempts, the pump max would turn on but would not stay on. It was reported that the nurse was standing behind the pump max and reaching over it each time to turn it on. After the third attempt, the nurse moved the pump max so that she could turn it on from the front and was able to fully depress the "on" button; however, the pump max did not turn on and was therefore, unplugged. After being unplugged, the pump max was restarted and the "on" switch was completely pushed. The procedure was then completed using the same pump max, an indigo system aspiration catheter 8 (cat8) and an indigo system separator 8 (sep8). 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
kathleen kidd
one penumbra place
alameda , CA 94502
5107483200
MDR Report Key5855283
Report Number3005168196-2016-01151
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 07/11/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX110
Device LOT NumberF22845-10
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/27/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/10/2016
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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