MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A.

Model Number UNK DY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, there was blood found on the bed of the patient despite no reported device leak at the time of connection, no total disconnection and no (pb) barometric pressure alarm on the machine.The patient underwent an emergency blood test, hospitalization by surveillance and two red blood cells transfusion.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• Manufacturer Contact: jacqueline st. pierre ; 15 hampshire street; mansfield, MA 02048 ; 5084524938
• MDR Report Key: 7499336
• MDR Text Key: 107785470
• Report Number: 3009211636-2018-00140
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK DY
• Device Catalogue Number: UNK DY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2018
• Initial Date FDA Received: 05/09/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 05/25/2018
• 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): Hospitalization; Required Intervention