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

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, 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 MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 30914
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problems Apnea (1720); Bradycardia (1751)
Event Date 02/14/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: scalpshort peripheral catheter, therapy date: (b)(6) 2018. The customer's report that the tubing cracked and leaked was confirmed. Visual inspection showed that the female luer had a vertical hair line crack measuring 0. 686 inches long. Inspection under magnification showed no stress marks. No issues were observed on the concomitant extension set. Functional testing resulted in a leak from the crack. The cause of the leak was a cracked female luer. The root cause is a manufacturing issue.
 
Event Description
The customer reported that tpn was programmed to infuse at 11. 6 ml/hr. Approximately 7 ml of blood was noted on the floor dripping from the iv tubing. Blood from the scalp iv had backed up and was leaking out of a hole in the tubing. A crack was noted near the connection of 2 extension sets. A stat cbc with diff, pt/inr, and ptt were ordered in addition to routine bmp, magnesium and phosphate levels. The patient appeared mottled (baseline) but otherwise normal. Vital signs were stable on initial assessment however the patient began having intermittent episodes of bradycardia to the 90s and periods of apnea with desaturations that required stimulation. The hematocrit was 23% which is below the transfusion threshold for this patient. The fio2 was increased to 100% but the patient continued to have shallow respirations. The patient was placed on 2 l hfnc (high flow nasal cannula) for additional stimulation and received 15 ml/kg of prbcs. The patient responded well to being placed on hfnc. Intermittent apnea and bradycardia resolved with no lasting harm. The patient's platelets, pt/inr and ptt were within normal limits.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICROBORE EXTENSION SET
Type of DeviceSET, EXTENSION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7328428
MDR Text Key102026242
Report Number9616066-2018-00244
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number30914
Device Catalogue Number30914
Other Device ID Number10885403233319
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
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: 03/09/2018 Patient Sequence Number: 1
Treatment
8015,21001M-07,8110, THERAPY DATE (B)(6) 2018
-
-