MAUDE Adverse Event Report: ST PAUL HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number 90

Device Problems Crack (1135); Display Difficult to Read (1181); Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 03/25/2020

Event Type  malfunction  

Event Description

Information was received indicating that the lcd to a smiths medical hotline blood and fluid warmer was reported to be dark, cracked, and liquid leaked out.There were no reported adverse effects.

Event Description

Information was received indicating that the lcd to a smiths medical hotline blood and fluid warmer was reported to be dark, cracked, and liquid leaked out.There were no reported adverse effects.It was further reported that the product problem was observed during quarterly testing at the facility.The testing occured on (b)(6) 2020.No patient injury or complications were reported in relation to this event.

Manufacturer Narrative

Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition.Visual inspection revealed a damaged board, worn line cord, crack tank cover, and a scuffed up enclosure.The customer reported product problem (liquid crystal leakage on the lcd display.) was confirmed during testing.The product problem occurred because of a faulty board.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The problem source of the reported product problem was unknown.A root cause was not established.The aforementioned components along with the loud pump were replaced.Preventative maintenance was then performed.The device subsequently passed functional testing.

• Brand Name: HOTLINE BLOOD AND FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 9987372
• MDR Text Key: 188557418
• Report Number: 3012307300-2020-03375
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

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: No Information
• Device Model Number: 90
• Device Catalogue Number: CON-HL-90
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1