Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS PCA MODULE; PUMP, INFUSION
  • 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
 

CAREFUSION SD ALARIS PCA MODULE; PUMP, INFUSION Back to Search Results
Model Number 8120
Device Problems Fail-Safe Problem (2936); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
Customer advocacy received a copy of the customer's maude report from the fda which stated, "pt was able to use a key on our alaris/bd carefusion model 8120 rca pumps to divert dilaudid and these keys can be bought of the internet this is the second time that this has happened and was able to determine it was the patient who had a key that she could use." there was no reported patient harm.
 
Manufacturer Narrative
The reported event of device had pca tampering was created to document the event that the customer reported.The customer did not return the device for evaluation.No device history search was performed since no source device serial number was reported by the customer.A review of the (b)(6) 2021 complaint review board (crb) did not find an increasing trend for the reported issue of ¿pca tampering".Based on the crb review and the limited information provided no further investigation actions will be performed.The device was not returned for investigation or repair.No failure data exists to review.Therefore, the proximate cause of the customer¿s reported issue cannot be determined.The reported issue that the 8120 alaris pca module pca tampering could not be confirmed; no product or device logs were returned for investigation.No further investigation of this event is possible at this time.The device is used for treatment purposes.H3 other text: device was not returned to manufacturing facility.
 
Event Description
Customer advocacy received a copy of the customer's maude report from the fda which stated, "pt was able to use a key on our alaris/bd carefusion model 8120 rca pumps to divert dilaudid and these keys can be bought of the internet this is the second time that this has happened and was able to determine it was the patient who had a key that she could use." there was no reported patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS PCA MODULE
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11803361
MDR Text Key250457628
Report Number2016493-2021-503897
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
PMA/PMN Number
K043299
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 04/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8120
Device Catalogue Number8120
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015; PCA TUBING
-
-