MAUDE Adverse Event Report: BURETTE SETS 150 ML.; INTRAVASCULAR ADMINISTRATION SET

Catalog Number DFP-87-FH

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2020

Event Type  malfunction  

Manufacturer Narrative

The reported lot # 20200917 was not found for the reported catalog # dfp-87-fh.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the burette sets 150 ml.Drew air into the empty chamber once disconnected from the dosifix system.The following information was provided by the initial reporter, translated from (b)(6) to english: "sometimes a vacuum is created in the system so that the blue float can no longer lift itself and the system has to be disconnected.In addition, it often draws in air once the chamber is empty.Potentially serious.Patient was not harmed as the users closely monitored the situation.Dosifix repeatedly formed a vacuum while it was connected to the patient, which had to be corrected and air had to be drawn in several times.Without constant intervention, this would have led to air embolism.".

Manufacturer Narrative

The following fields were updated due to corrected information: d.4.Medical device lot #: 20200917.H.6.Investigation: a dfp-87-fh product was not available for investigation; however the customer confirmed that the complaint sample was from lot 20200917.From the information provided by the customer it appears that the blue float valve wouldn't float, which resulted in an occlusion.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the legal manufacturer, anhui tiankang medical products co.,ltd, for investigation.A review of the production records from lot 20200917 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.H3 other text : see h.10.

Event Description

It was reported that the burette sets 150 ml.Drew air into the empty chamber once disconnected from the dosifix system.The following information was provided by the initial reporter, translated from german to english: "sometimes a vacuum is created in the system so that the blue float can no longer lift itself and the system has to be disconnected.In addition, it often draws in air once the chamber is empty.Potentially serious.Patient was not harmed as the users closely monitored the situation.Dosifix repeatedly formed a vacuum while it was connected to the patient, which had to be corrected and air had to be drawn in several times.Without constant intervention, this would have led to air embolism.".

• Brand Name: BURETTE SETS 150 ML.
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12240143
• MDR Text Key: 264054652
• Report Number: 2243072-2021-01971
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: DFP-87-FH
• Device Lot Number: 20200917
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• 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