MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH PRISMAFLO IIS; BLOOD WARMER

Model Number NO INFORMATION

Device Problems Thermal Decomposition of Device (1071); Nonstandard Device (1420); Overheating of Device (1437)

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

Event Type  malfunction  

Manufacturer Narrative

Further investigations are not possible as the defective heating profile was not available for investigation and s/n of defective heating profile was not transmitted.Should additional relevant information become available, a supplement report will be submitted.Because of the characteristics of this event the manufacturer judges that this event fits in the recall of this product that addresses the potential failure.As soon as the healthcare provider responds to the "urgent medical device correction" form from stihler electronic the affected heating profiles will be replaced.There was no patient injury or medical intervention associated with this event.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a blood warmer prismaflo iis.The nurse noticed a small white glowing on the heating profile.The heating profile had a small (less then 1 cm diameter).Dark brown circle on it.The prismaflex blood tubing was not burnt through.Treatment was discontinued.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLO IIS
• Type of Device: BLOOD WARMER
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• Manufacturer (Section G): STIHLER ELECTRONIC GMBH; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• Manufacturer Contact: michael schelling ; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• MDR Report Key: 8342352
• MDR Text Key: 136520521
• Report Number: 9617473-2018-00002
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• PMA/PMN Number: K082758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NO INFORMATION
• Device Catalogue Number: NO INFORMATION
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 02/15/2019
• 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: Reuse
• Patient Sequence Number: 1