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

Model Number PF2-WP33

Device Problems Nonstandard Device (1420); Smoking (1585)

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.Should additional relevant information become available, a supplement report will be submitted.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 warming sheath (product code: unknown; serial number: (b)(4)) and the reference number is (b)(4).The prismaflex machine was set-up and primed for an els treatment when smoke was noticed coming from the warming sheath.The sheath was immediately unplugged, removed, and sent to biomed for inspection.The renal nurse practitioner examined the blood lines and they did not appear to be affected, so treatment was started with a new sheath.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: 9207112
• MDR Text Key: 168576522
• Report Number: 9617473-2019-00003
• 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: 10/18/2019
• 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
• Date Manufacturer Received: 10/15/2019
• 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
• Removal/Correction Number: Z-0759-2019
• Patient Sequence Number: 1