MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LEVEL 1 H-1200 FAST FLOW FLUID WARMER; BSB - WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number H-1200

Device Problems Accessory Incompatible (1004); Insufficient Flow or Under Infusion (2182)

Patient Problem Death (1802)

Event Type  Death  

Event Description

The user facility reported that the device was in use with a patient for intraosseous infusion of iv fluids.It was reported that the user facility switched the infusion form iv fluids to packed red blood cells and when the blood reached the distal portion of the primed tubing, flow stopped and pressure built up in the tubing.The user facility was unable to infuse packed red blood cells with the infusion set.The user facility attempted to use a replacement device and three replacement administration sets without success for intraosseous infusion of packed red blood cells.The patient expired due to sustained injuries received prior to treatment.According to reporter, device user sustained blood exposure when they disconnected the patient line after procedure; the user was admitted to emergency department for post exposure prophylaxis.No adverse effects to the user were reported.

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

• Brand Name: LEVEL 1 H-1200 FAST FLOW FLUID WARMER
• Type of Device: BSB - WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; rockland MA
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: pete hirte ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287384
• MDR Report Key: 3947275
• MDR Text Key: 4642287
• Report Number: 2183502-2014-00482
• Device Sequence Number: 1
• Product Code: BSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK020043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H-1200
• Device Catalogue Number: H-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2014
• Event Location: Hospital
• Date Manufacturer Received: 06/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death