MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V; JCX

Catalog Number PMX220

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the inlet port for the power cord was damaged.The penumbra system aspiration pump max 220v (pump max) was opened by a penumbra investigator and 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 generated vacuum.The pump was opened by the penumbra investigator and corrosion was observed on the piston crown of the outlet cylinder.The observed corrosion may have caused the piston to seize inside the cylinder.It is likely that the seized piston became freed-up during transit, allowing the pump to function during penumbra evaluation.Further evaluation revealed the inlet port of the power cord was damaged.The root cause of this complaint cannot be determined.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 using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max was switched on, however, no vacuum was produced.The procedure was completed by manual aspiration using a syringe.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5574940
• MDR Text Key: 42618267
• Report Number: 3005168196-2016-00488
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F19958-23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 88 YR