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

MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SETS SET, ADMINISTRATION, INTRAVASCULAR

  • 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 PRIMARY TUBING SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problems Infusion or Flow Problem (2964); Unintended Movement (3026)
Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that primary tubing sets roller clamp was released and the patient experienced bradycardia and hypertension. The following information was provided by the initial reporter: material no: unknown batch no: unknown. Rn was in the process of a routine iv tubing change of vasopressin and norepinephrine. Rn connected newly primed tubing of one bag to the pump and incidentally released the roller clamp on the bag not attached to the pump so the patient may have received a small amount of norephinephrine before the bag was reclamped. Patient experienced a short episode of bradycardia and hypertension and recovered. No harm evident, physical or otherwise.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePRIMARY TUBING SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 s state st
sandy UT 84070 3213
Manufacturer Contact
brett wilko
9450 s state st
sandy, UT 84070-3213
8015652341
MDR Report Key10286724
MDR Text Key199283839
Report Number9616066-2020-02244
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/16/2020 Patient Sequence Number: 1
-
-