MAUDE Adverse Event Report: ALCON - BELGIUM/ALCON N.V. CUSTOM PAK; CONVENIENCE KIT

Model Number CUSTOM PAK

Device Problem Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A nurse reported that a system message was displayed during priming.Surgeon could clear the message however, there was no aspiration during surgery.They tried to take the cassette out but the same system message was displayed.No patient harm was reported.Additional information has been requested but not received to date.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested but not received to date.(b)(4).

• Brand Name: CUSTOM PAK
• Type of Device: CONVENIENCE KIT
• Manufacturer (Section D): ALCON - BELGIUM/ALCON N.V.; medialaan 36; vilvoorde B-180 0; BE B-1800
• Manufacturer (Section G): ALCON - BELGIUM/ALCON N.V.; medialaan 36; vilvoorde B-18 00; BE B-1800
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4412230
• MDR Text Key: 5376549
• Report Number: 3002037047-2014-00177
• Device Sequence Number: 1
• Product Code: KYG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM PAK
• Device Catalogue Number: CUSTOM PAK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: PACK, INT PL 0.9MM ULTRA (DATE UNK)