MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH PRISMAFLO II; WARMER, THERMAL, INFUSION FLUID

Device Problems Insufficient Heating (1287); Device Displays Incorrect Message (2591)

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

Event Date 07/28/2016

Event Type  malfunction  

Event Description

"broken equipment" blood warmer on the crrt.Warmer did not heat up as it should.Error message on the screen showed "e".Sequestered warmer.Clinical engineering has the warmer, investigation ongoing.Report to follow.What led to event: sensor of the warmer could go bad on transport (shaking) or bleaching or age of device (this 3 yrs old) could be manufacturing.Clinical engineering still investigating.Prismaflo ii.

• Brand Name: PRISMAFLO II
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; 30 northport rd; po box 1257; sound beach NY 11789
• MDR Report Key: 5842656
• MDR Text Key: 51018551
• Report Number: 5842656
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: CE L131814
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2016
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 YR