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

Model Number PF2-WP2618

Device Problems Nonstandard Device (1420); Overheating of Device (1437)

Patient Problems Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Type  malfunction  

Manufacturer Narrative

Based on the investigation is that the heating wire of the heating profile was internally damaged due to external mechanical stress additionally the heating profile had contact to patient's thigh.There is also a strong doubt if the cleaning and disinfecting methods (only with alcohol-based disinfectant agents or ready-to-use disinfectants) for the heating profile were followed correctly (according the instructions for use).The combination of these factors must have lead to the local overheating of the heating profile and consequently to the burn.The burn mark was classified as second degree burn and is not judged as serious injury.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.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a blood warmer prismaflo ii.Heating profile overheated and caused blistering burns on the patient's thigh.Treatment was discontinued.Patient burn was treated in accordance with hospital protocol.

• Brand Name: PRISMAFLO II
• 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: jens-peter weege ; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• MDR Report Key: 9320977
• MDR Text Key: 206362336
• Report Number: 9617473-2019-00004
• 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

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PF2-WP2618
• Device Catalogue Number: PF2-WP2618
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2019
• 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
• Removal/Correction Number: Z-0761-2019
• Patient Sequence Number: 1