MAUDE Adverse Event Report: SMITH'S MEDICAL ASD. INC. HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number HL-90115V

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2015

Event Type  No Answer Provided  

Event Description

The patient was receiving blood through the hotline warming device.The blood products were placed on a machine.The patient was receiving blood through the alaris pump and then through the hot line pump.The hotline pump appeared to malfunction as the blood products were being pumped into the sterile water reservoir chamber.Everything was disconnected from the patient.There was no change in the patient's condition.At this time, we can not determine if the blood products mixed with the sterile water and this was infused into the patient or not.The alaris pump, the blood products warmer as well as the tubing are being examined by our biomed department.

• Brand Name: HOTLINE FLUID WARMER
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMITH'S MEDICAL ASD. INC.; 160 weymouth st.; rockland MA 02370
• MDR Report Key: 4549120
• MDR Text Key: 5521214
• Report Number: 4549120
• Device Sequence Number: 1
• Product Code: LGZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Device Operator: Invalid Data
• Device Model Number: HL-90115V
• Device Catalogue Number: L-70
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALARIS PUMP, FLUID WARMING SET TUBING
• Patient Age: 53 YR