MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1731

Device Problems Failure to Zero (1683); Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 02/15/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Upon completion of the investigation, a follow up report will be filed.

Event Description

Evd that was difficult to drain and would not zero - even when new transducer was attached.Vcu is concerned that this exposed patient to risk fo infection and inaccurate icp values because they had to replace the old drain with a new eds# drain.The eds3 drain was replaced by another drain.No delay reported.

Manufacturer Narrative

Device evaluation: upon completion of the investigation it was noted that the eds iii was visually inspected, the eds iii was set up as per ifu.A brownish liquid was found in the collection bag, as well as biological debris stains on the filter inside the drip chamber.The brownish liquid was emptied from the collection bag.The drip chamber stop cock was turned to the off position.20ml of purified water was flowed into the drip chamber.The system stopcock was then closed, the drip chamber stopcock was opened; the purified water flowed normally and emptied into the collection bag.This process was repeated with the same result, the eds iii functions.Review of the history device records was not possible as the lot number was unknown.No root cause was determined as the eds iii functioned.Based on the results of this investigation no further action is required.Trends will be monitored for this and similar complaints.At the present time this complaint is closed.

• Brand Name: CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5477107
• MDR Text Key: 39585345
• Report Number: 1226348-2016-10170
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 82-1731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention