MAUDE Adverse Event Report: PRISMAFLO II; BLOOD WARMER

Model Number 113282

Device Problem Insufficient Heating (1287)

Patient Problem Hypothermia (1915)

Event Date 08/28/2016

Event Type  Death  

Manufacturer Narrative

The prismaflo ii blood warmer was not returned for analysis.The prismaflex control unit used for the crrt treatment does not offer means of warming blood circulating in the extracorporeal circuit.Should warming be clinically indicated an external blood warmer can be used with the prismaflex system.The prismaflex control unit does not have any supervision of external blood warmers connected to the prismaflex system, as there is no communication between them.The temperature of the heating profile is monitored by a temperature control system and by independent alarm systems which draw the operator's attention to alarm reactions and switch off the healing process automatically in the event of excessive temperature.During operation, the control panel shows the internal temperature of the heating profile (not equal to the temperature of the fluid to be warmed).This means that the prismaflo ii does not regulate the actual temperature of the medium to be warmed nor does it monitor the temperature.This temperature is dependent on a variety of additional factors (room temperature, outlet temperature of the fluid to be warmed, flow rate).Monitoring of patient core temperature shall be done by medical staff.The need for the latter is stressed in the operator's manual for the prismaflex control unit.The prismaflex control unit ((b)(4)) was inspected after the reported event and was found to be working within manufacturer specifications.

Event Description

A patient in the picu hospitalized for a month had uncontrolled seizures of unknown origin with other debilitating medical issues including hypothermia.Reportedly, the patient's temperature at one point during the hospitalization and prior to crrt was down to 33.8 c.She was on a bair hugger and a warming pad.The patient became oliguric and began continuous renal replacement therapy (crrt) utilizing a prismaflo ii blood warmer.At the beginning of crrt the patient's temperature was 36.10 c (axillary) and the blood warmer was set to 41.0 c.Two hours later the patient's temperature had decreased and the blood warmer was increased to 43.0 c; the warmer registered 42.6 c.Seven hours into treatment the patient showed signs of increasing hypothermia with a decreased heart rate.At some point, the patient fluid removal rate was set to zero.The prismaflex blood flow rate was set at 50 ml/min and remained at this rate throughout treatment.Crrt was terminated approximately 15 hours after it was initiated due to ongoing hypothermia.Two hours after terminating crrt the patient's body temperature began to increase.An hour later the patient coded.Resuscitation efforts were unsuccessful and the patient expired.An autopsy was not performed at the family's request.

• Brand Name: PRISMAFLO II
• Type of Device: BLOOD WARMER
• Manufacturer Contact: sebastien detemmerman ; box 10101; se-220 10 lund; lund se, ; SW ; 6169381
• MDR Report Key: 5981895
• MDR Text Key: 55786824
• Report Number: 9616026-2016-00010
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 113282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2016
• Distributor Facility Aware Date: 08/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2016
• Date Manufacturer Received: 08/29/2016
• 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: N
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX; PRISMAFLEX M 60
• Patient Outcome(s): Death
• Patient Age: 24 MO
• Patient Weight: 10