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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; Sparking
Event Date 11/23/2016
Event Type  Malfunction  
Manufacturer Narrative

This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.

 
Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 220 (pump max). During the procedure, while in use, the physician noticed some sparks coming out the pump max outlet. Subsequently, the pump max stopped working and was unable to turn on afterward; therefore, the procedure was completed by manual aspiration using a syringe. There was no report of an adverse effect to the patient.

 
Manufacturer Narrative

Results: the penumbra system aspiration pump max 220 (pump) was found to have two blown fuses prior to powering on the pump. When plugging the pump in, there was a spark and a buzzing sound. The fuse in our step up transformer was blown. The electrical socket was found to have been burnt and shows burns to the bottom of the pump. Upon opening the pump, the vacuum pistons were found to be corroded. The back of the pump shows the vent grill broken outwards. The inside of the pump housing shows signs of carbon and dust residue. Rust was found on the pump chassis near the electrical outlet. Conclusions: evaluation of the returned device confirmed that an electrical spark occurred once the pump max was connected to a live power source. Prior to connecting the pump max, a penumbra investigator confirmed that both fuses in pump max were blown, and that the device on/off switch was in the off position. Further evaluation revealed corrosion both on the base plate, as well as inside both cylinders of the vacuum pump. Signs of corrosion were also observed on the brass fittings inside the pump housing. It is postulated that the moisture that caused the corrosion observed inside the pump likely contributed to the short circuit and subsequent arching inside the pump. These types of damage likely occurred due to improper storage conditions of the pump max. Further evaluation revealed that the pump max housing was damaged and a carbon build-up was present inside the pump housing likely attributed to the preceding sparking/arching. This finding further corroborates that the pump max was likely improperly stored and manipulated. 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.

 
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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 Key6200194
Report Number3005168196-2016-01886
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,HEALTH PR
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device Catalogue NumberPMX220
Device LOT NumberF10970-08
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/28/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/06/2014
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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