MAUDE Adverse Event Report: ST. WENDEL AG ULTRAFLUX AV 600 S; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 5007361

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Plant investigation: the reported complaint was not confirmed as the complaint device was not returned for manufacturer evaluation and photographs were not provided.A review of the instructions for use (ifu) revealed that the reported event is adequately addressed in the current version.All dialyzers are 100% tested for leaks (bubble-point and air testing during sterilization); however, leaks due to adverse environmental conditions or mechanical stress during treatment may occur in very few cases.A production records review was performed on the reported lot.An investigation of the device history records (dhr) was conducted by the manufacturer.There was no indication of product nonacceptance, deviation, non-conformance, rework, labeling or process control failure during the manufacturing process which could be associated with the reported event.The lot met all release criteria.A definitive conclusion regarding the complaint incident cannot be reached without physical examination of the actual device.Therefore, the complaint is not confirmed.

Event Description

It was reported that a dialyzer blood leak occurred during a patient's dialysis treatment.The patient's estimated blood loss (ebl) was reported to be less than or equal to 50 ml.There were no reported adverse effects experienced by the patient, and no indication that medical intervention was required as a result of the event.The product sample was not available to be returned for a manufacturer evaluation.No further details could be obtained.

• Brand Name: ULTRAFLUX AV 600 S
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): ST. WENDEL AG; director of quality; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer (Section G): ST. WENDEL AG; director of quality; frankfurter str. 6-8; st. wendel 66606 ; GM 66606
• Manufacturer Contact: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11052520
• MDR Text Key: 228048806
• Report Number: 3002807005-2020-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EUA200149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5007361
• Device Lot Number: Z1BF25102
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1