MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Device Alarm System (1012)

Patient Problems Headache (1880); Nausea (1970)

Event Date 05/24/2021

Event Type  malfunction  

Event Description

Information was received indicating that while in use of a smiths medical cadd cassette reservoir, a no disposable, clamp tubing alarm was noted.It was also reported that the patient complained of headache, nausea, and stomachache.Subsequently, the cassette was changed, and alarm was cleared.No further adverse effects were reported.

Manufacturer Narrative

H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Samples received: the sample consist in one (1) cassette product from part number 21-7302-24 and lot number 4063420; the returned sample was received in used conditions decontaminated and inside in a plastic bag.Visual inspection: the sample was visually inspected at a distance of 12? to 16? under normal conditions of illumination to detect samples conditions that could cause functional issues.Results: the sample didn?t present any damage, scuffs, pinch marks, cracks, crazing, etc.Could cause the failure mode reported.Functional testing: sample was filled with water; the sample was connected to the cadd solis vip to look for unusual function.Results: the sample was fully priming and connected without difficult, the pump was set running and the alarm was not activated.The complaint was not confirmed.No actions taken were performed since the complaint was not confirmed.The cause of the reported problem could not be determined.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12084163
• MDR Text Key: 258902409
• Report Number: 3012307300-2021-06628
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4063420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: Asian