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

Catalog Number PMX220

Device Problems Failure to Pump (1502); No Pressure (2994); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2016

Event Type  malfunction  

Manufacturer Narrative

Please note that the following device code also applies to this complaint (b)(4).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 220v (pump max).During the procedure, the pump max was plugged in and switched on properly; however, the pump max made an unusual dull noise and no vacuum was being produced.The physician unplugged the pump max and then plugged it back into different sockets but the pump max still did not produce vacuum.Since a sheath was already introduced into the patient's groin, the physician decided to treat the patient with lytics.While the nurses were preparing the materials for the lytics treatment, the pump max was still being troubleshot and then suddenly started to work and produce vacuum.Therefore, the procedure was successfully completed using this same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Result: the penumbra aspiration pump max (pump max) was able to power up and achieve full vacuum.The pump max was opened by the penumbra investigator and corrosion was found inside the pump max.Conclusion: evaluation of the pump max revealed the pump was capable of powering up and producing full vacuum.The regulator knob was able to effectively regulate pressure.The penumbra investigator opened the device and upon this further investigation, corrosion was found in the outlet piston.The observed corrosion likely caused the piston to seize inside the cylinder, causing the pump to fail to generate vacuum.It is likely that the seized piston became freed during attempts to troubleshoot the pump max.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.

• 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: 5834591
• MDR Text Key: 50909680
• Report Number: 3005168196-2016-01079
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F21927-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2016
• 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