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

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.

• Brand Name: PERIFIX .2UM FLAT EPIDURAL FILTER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL, INC; 901 marcon boulevard; allentown PA 18109
• MDR Report Key: 5899680
• MDR Text Key: 52921315
• Report Number: 5899680
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 02/01/2021
• Device Model Number: FEF100
• Device Catalogue Number: 415000
• Device Lot Number: 0061486629
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/22/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALARIS PCA PUMP MODEL 8120.