MAUDE Adverse Event Report: CAREFUSION SHUNT DENVER ASCITES PAK DOUBLE VALVE; SHUNT, PERITONEAL

Model Number 42-2050

Device Problem Mechanics Altered (2984)

Patient Problem No Patient Involvement (2645)

Event Date 02/01/2013

Event Type  malfunction  

Event Description

During incoming inspection, the customer noted that there seems to be a scar on the peritoneal tubing ner the pump chamber.

Manufacturer Narrative

(b)(4).In response to an fda inspection ((b)(4)), carefusion 2200 initiated a capa investigation (capa is (b)(4)).As part of the capa, a retrospective review of the complaints for "debris" and "contamination" for applicable devices was conducted.It was determined that this report necessitates submission as a medical device report (mdr).Evaluation summary: one (1) unopened sample was provided for evaluation.Evaluation of the complaint sample confirmed the presence of a loose flake of silicone adhesive on the exterior wall of the chamber.It has been identified that this failure mode is not an isolated event.A thorough review of applicable manufacturing procedures identified a specific manufacturing step that may have contributed to the reported failure mode.A device history record (dhr) review, raw material history files, and the sterilization batch records for the listed manufacturing lots showed no recorded quality problems or rejections related to this incident.Based on the investigation results, the root cause for this failure mode was identified as a process error (loose silicone adhesive generated during the manufacturing of the affected unit within lot 0000478616), which generated the confirmed failure mode of a loose flake of silicone adhesive on the external surface of the shunt chamber.The manufacturing plant has also initiated a capa investigation (b)(4)) to address the reported issue.All corrective and preventive actions (including manufacturing and quality plan improvements) will be implemented per the capa.

• Brand Name: SHUNT DENVER ASCITES PAK DOUBLE VALVE
• Type of Device: SHUNT, PERITONEAL
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION 2200, INC; 400 east foster rd; mannford 74044
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4131615
• MDR Text Key: 4918921
• Report Number: 1625685-2014-00135
• Device Sequence Number: 1
• Product Code: KPM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011862
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 42-2050
• Device Lot Number: 0000478616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2013
• Date Manufacturer Received: 02/01/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1