MAUDE Adverse Event Report: ECOLAB / MICROTEK MEDICAL INC. WARMER, IRRIGATION SOLUTION; FLUID WARMING AND SLUSH DRAPE

Model Number ORS-321N

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/28/2019

Event Type  malfunction  

Event Description

It was reported that during two procedures, fluids were absorbed by the drape and "pooled under it causing contamination".No patient complications have been reported as a result of this event.

• Brand Name: WARMER, IRRIGATION SOLUTION
• Type of Device: FLUID WARMING AND SLUSH DRAPE
• Manufacturer (Section D): ECOLAB / MICROTEK MEDICAL INC.; zona franca no. 2; la romana, ; DR
• Manufacturer (Section G): ECOLAB/ MICROTEK MEDICAL INC.; 1 ecolab place; st paul MN 55102
• Manufacturer Contact: anuli okolo-young ; 1 ecolab place; st paul, MN 55102 ; 6512502237
• MDR Report Key: 8436334
• MDR Text Key: 139324282
• Report Number: 8043817-2019-40016
• Device Sequence Number: 1
• Product Code: LHC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2020
• Device Model Number: ORS-321N
• Device Lot Number: D153341
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1