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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CLEO® 90 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7230-24
Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923)
Patient Problems Hyperglycemia (1905); Discomfort (2330); Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Manufacturer Narrative
Customer has not returned the device to the manufacturer for device evaluation. If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
 
Event Description
It was reported that a cleo® 90 infusion set was in use with a patient when an uncontrolled spike in blood glucose was observed. It was initially reported that the issue was observed after two days of device use but then it was reported that the site was removed due to the high blood glucose within 32 hours after initial placement and after more than 6 hours of "unresponsive [blood glucose] to insulin provided. " the blood glucose was noted to have peaked around 400 mg/dl and a site change was conducted immediately. Upon site removal, it was observed that the infusion set tubing remained in the patient's body under her skin and lodged into the patient's tissue. It was suspected that the site breakage occurred prior to removal. It was noted that the site was placed and adhered normally after the area was thoroughly cleaned, skin tac applied, and allowed to dry. The patient was unable to remove the tubing on her own and experienced discomfort. The patient was taken to the emergency room for removal after two days from the incident. An unsuccessful attempt was made to remove the infusion set tubing. The patient was discharged with instruction to observe for infection and the discharge of the foreign body. The tubing remains in the patient's body and an appointment with an endocrinologist was made to consider an outpatient surgical removal. The event is considered ongoing. No permanent injury was reported. See mfr: 3012307300-2017-00191.
 
Manufacturer Narrative
The reporter returned a device for investigation. The device was not properly labelled prior to shipment and therefore was not properly identified at receiving.
 
Event Description
It was further reported that while at the emergency room, the patient received multiple numbing injections prior to the health professional's attempt to remove the infusion set cannula. The patient placed the cleo® 90 infusion set around their midsection (belly/abdomen and upper side area). According to the report, the cannula remains inside the patient and the patient's body was not dislodging the cannula. It was reported that the patient was advised that they will need to see a general or plastic surgeon to have the cannula removed. No information was provided regarding the potential date of the surgery.
 
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Brand NameCLEO® 90 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MFG
s.a. de c.v. ave calidad no. 4
parque industrial internaciona
tijuana, b.c. 22425
MX 22425
Manufacturer Contact
lisa perz
6000 nathan lane north
minneapolis, MN 55442
7633833074
MDR Report Key6249001
MDR Text Key64736838
Report Number3012307300-2017-00190
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042172
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7230-24
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
Was Device Evaluated by Manufacturer? No Answer Provided
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: 01/13/2017 Patient Sequence Number: 1
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