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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 Failure to Power Up; Device Operates Differently Than Expected
Event Date 01/28/2017
Event Type  Malfunction  
Manufacturer Narrative

Results: there was no damage to the exterior of the penumbra system aspiration pump max 220 (pump). Corrosion was observed inside the pump piston cylinders. The pump inlet cylinder was severely corroded, and moisture was observed in the inlet cylinder head, as well as the inlet tubing and the tubing connecting the inlet cylinder to the outlet cylinder. Conclusions: evaluation of the returned device revealed that the pump was non-functional. The pump was plugged in and powered on. The cooling fan turned on, but no vacuum was generated. The penumbra investigator opened the pump and corrosion was found inside the cylinders. Further evaluation revealed moisture in the inlet cylinder head, as well as the inlet tubing and the tubing connecting the inlet cylinder to the outlet cylinder. If the aspiration tubing is connected directly to the vacuum inlet rather than the canister supplied by penumbra, fluid will likely enter the pump assembly, and may cause corrosion. This corrosion likely caused the piston to become seized, and prevented the pump from generating vacuum. Penumbra pumps are visually and functionally inspected 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 using a penumbra system aspiration pump max 220 (pump max). Upon attempting to turn on the pump max to begin aspiration with the penumbra system ace 68 reperfusion catheter (ace 68), the nurse noticed the pump max was unable to power on; therefore, the pump max was not used in the procedure. The procedure was completed using manual aspiration and the same ace 68.

 
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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 Key6373443
Report Number3005168196-2017-00293
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/03/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/02/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF11540-03
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/03/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/20/2014
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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