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

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

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.

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.

• Brand Name: CADD® EXTENSION SETS
• Type of Device: SET, 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 Key: 6461859
• MDR Text Key: 71824155
• Report Number: 3012307300-2017-00807
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• 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 Received: 04/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 56X106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 100 ML MEDICATION CASSETTE; CADD LEGACY PUMP; PICC; VELETRI (EPOPROSTENOL)
• Patient Outcome(s): Other
• Patient Age: 16 YR