MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7343-24

Device Problem Filling Problem (1233)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The sample was returned for investigation.A visual inspection was performed, and a kink was detected on the pump tube in the sample.A functional test was performed and there was resistance at moment to pass for the kink generate on the ffp system.The reported failure was not confirmed.The root cause cannot be established.There were no relevant findings detected in the device history review.

Event Description

It was reported that 3 lines could not be filled.No patient injury was reported.

Manufacturer Narrative

While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-07845 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14311118
• MDR Text Key: 290951761
• Report Number: 3012307300-2022-07845
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: 15019517191820
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7343-24
• Device Catalogue Number: 21-7343-24
• Device Lot Number: 4012756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1