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

Model Number PF2-WP33

Device Problems Thermal Decomposition of Device (1071); Nonstandard Device (1420); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

The heating device (warming tubing), which was described in the event description, is not a part of the prismaflex dialysis system manufactured by baxter.This device is a blood warmer prismaflo iis manufactured by stihler electronic as an accessory to prismaflex dialysis system.It is intended to warm the blood return line during prismaflex crrt treatment.Because of the characteristics of this event the manufacturer judges the event fits in the recall for this product that addresses this potential failure.There was no patient injury or medical intervention associated with this event.

Event Description

It was reported that a nurse noticed the return tube was extremely hot.Upon inspection the nurse found a hole burned in the warming tubing and a burn mark on the return line.The nurse stopped the continous renal replacement therapy (crrt).The nurse notified the dialysis nurse.The prismaflex was switched out with another prismaflex.There was no patient injury or medical intervention associated with this event.

• 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: jens-peter weege ; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• MDR Report Key: 8554079
• MDR Text Key: 143532490
• Report Number: 9617473-2019-00002
• 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: No Information
• Device Model Number: PF2-WP33
• Device Catalogue Number: PF2-WP33
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 04/26/2019
• 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-0759-2019
• Patient Sequence Number: 1