MAUDE Adverse Event Report: PALL MEDICAL PALL DATA 5 SOFTWARE

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Information (3190)

Event Date 01/11/2014

Event Type  Injury  

Event Description

The pall data 5 software presented an o2 level reading of "pass" for a sample pouch test result.The test result values were indicative of an invalid test result according to cbc standard operating procedure.Upon completion of investigations, it was discovered that the sampling membrane had not been penetrated; therefore, the sample pouch had not been sampled for testing using the pall ebds oxygen analyzer.The system relies on a manual check by the user to detect the invalid result.No safeguards are provided by the system to prevent products with invalid results from being released as acceptable.

• Brand Name: PALL DATA 5 SOFTWARE
• Type of Device: DATA 5 SOFTWARE
• Manufacturer (Section D): PALL MEDICAL; 25 harbor park drive; fort washington NY 11050
• MDR Report Key: 3652806
• MDR Text Key: 19483816
• Report Number: MW5034742
• Device Sequence Number: 1
• Product Code: LNX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention