• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC PERIFIX .2UM FLAT EPIDURAL FILTER ANESTHESIA CONDUCTION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

B. BRAUN MEDICAL, INC PERIFIX .2UM FLAT EPIDURAL FILTER ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number FEF100
Device Problem Occlusion Within Device (1423)
Patient Problem Irritability (2421)
Event Date 08/18/2016
Event Type  malfunction  
Event Description
Nurses reported as part of the acute pain service team, they have been seeing more occlusion alerts then usual on the alaris pca pumps (carefusion model 8120) when they infuse an epidural. During one day, three of the five patients with epidurals had occlusion alarms on the patient side (of the tubing). When the problem first began (6 weeks ago) nurses would change out the yellow tubing (carefusion pca administration set, ref# 30893) however, that did not stop the problem of occlusion alarms. They started a step by step process to determine the issue by first changing tubing, then pumps, and then the inline filters. At this point it appears the filters being used as per protocol seem to be the cause of the occlusion alarms. The nurses prime the tubing and filter (b. Braun perifix flat epidural filter ref#415000) through the pump. Then during use and as occlusions occur, they disconnect the tubing from the patient and pressure prime the tubing and filter to clear any potential air bubbles. As a result of this occlusion error and the multiple actions the nurses are having to take to clear the alarm, the patient's therapy is being interrupted for extended amounts of time. In addition, because the pump must be physically silenced every time an alarm goes off, the patients are becoming increasingly irritated at the constant beeping coming from the pump. Our hospital process is to use a filter whenever an epidural is performed. After this happening many times when used with a filter, we suspect the filter as being the issue. Clinical engineering has done extensive testing on the carefusion model 8120 pump and can find no error with the pump.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePERIFIX .2UM FLAT EPIDURAL FILTER
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
B. BRAUN MEDICAL, INC
901 marcon boulevard
allentown PA 18109
MDR Report Key5899680
MDR Text Key52921315
Report Number5899680
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 08/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2016
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Model NumberFEF100
Device Catalogue Number415000
Device Lot Number0061486629
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/22/2016
Event Location Hospital
Date Report to Manufacturer08/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/24/2016 Patient Sequence Number: 1
Treatment
ALARIS PCA PUMP MODEL 8120.
-
-