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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD® EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7106-24
Device Problem Break (1069)
Patient Problems Burning Sensation (2146); Collapse (2416)
Event Date 03/14/2017
Event Type  Injury  
Manufacturer Narrative
Fourteen unused and one used cadd® extension sets were received for investigation. A visual inspection was performed, showing no nonconformities in the unused samples and a broken luer in the used sample. A review of the manufacturing process of a similar device was performed, and no discrepancies were found. The root cause was found to most likely be that the luer component was received cracked from the supplier, and was not detected through the "in process" inspection. The complaint was confirmed.
 
Manufacturer Narrative
Smiths medical has received the sample device. A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site. Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.
 
Event Description
It was reported that during patient use of the cadd® extension set the line broke at the connector and the patient collapsed. According to the report, at 6:00 pm, the patient had a burning feeling in their chest and "lost the veletri flushing". At 6. 10 pm it was noted that the patient's hands looked "normal". At 6:30 pm the patient collapsed and the mother of the patient removed the cassette from the bag and noted that the bag was wet. It was reported that examination of the cassette found that the line was broken at the connector and the parent of the patient stated that the line appeared to have "snapped then tore". It was reported that the event occurred after hours and the doctor was called. The extension line and medication cassette was changed. The patient was receiving veletri (espoprostenal) which was initiated on (b)(6) 2015. The veletri was being administered via a peripherally inserted central catheter (picc) which was inserted on (b)(6) 2016 and was changed on (b)(6) 2017. The dosage that the patient was receiving at the time of the event was two daily doses of 1. 5 mg of veletri at a concentration of 3-8 ng/kg/min with water being used as a diluent. The veletri was being administered via a peripherally inserted central catheter (picc) which was inserted on (b)(6) 2016 and was changed on (b)(6) 2017. It was reported that the incident was resolved after the change of the extension set.
 
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Brand NameCADD® EXTENSION SETS
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 Key6461859
MDR Text Key110478473
Report Number3012307300-2017-00807
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Expiration Date02/28/2021
Device Catalogue Number21-7106-24
Device Lot Number56X106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/18/2016
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: 04/05/2017 Patient Sequence Number: 1
Treatment
100 ML MEDICATION CASSETTE; CADD LEGACY PUMP; PICC; VELETRI (EPOPROSTENOL)
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