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 PCA ADMINISTRATION KIT AND REUSABLE MONOJET PLUNGER ROD
  • 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 PCA ADMINISTRATION KIT AND REUSABLE MONOJET PLUNGER ROD Back to Search Results
Model Number 10800173
Device Problems Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)
Patient Problem Pain (1994)
Event Date 05/10/2017
Event Type  malfunction  
Event Description
The pt transferred to the micu with severe abdomen pain not relieved by the hydromorphone pca.Upon investigating the pca settings and equipment it was noted that the tip of the microbore tubing segment that attached to the pca syringe was almost completely severed.The pca pump alarm read standby, only making it impossible to determine the direct issue with the pca infusion without close inspection of the entire system, medication and pump included.The pump post plunger connected to the microbore tubing segment does not have any checks in place to make sure the medication is infusing into the pt is intended.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PCA ADMINISTRATION KIT AND REUSABLE MONOJET PLUNGER ROD
Type of Device
PCA ADMINISTRATION KIT AND REUSABLE MONOJET PLUNGER ROD
Manufacturer (Section D)
CAREFUSION
MDR Report Key6572292
MDR Text Key75434457
Report NumberMW5069816
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/15/2017
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 Model Number10800173
Device Lot Number11611800
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/15/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
PCA PUMP
Patient Age45 YR
-
-