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

Model Number 21-7394-24

Device Problems Device Alarm System (1012); Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

Additional contact: (b)(6).Reporter: pharmacy supervisor.

Event Description

Information was received indicating that a smiths medical cadd administration set being caused a pump to have an occlusion error.It appeared that the tubing was kinked by/in the cassette.It was reported that the patient bag was not infusing; the pump was giving an occlusion error.The pump was changed and the same error was received.The tubing was troubleshooted.The kink was identified by the caregiver in the cassette area.The caregiver was able to hold open the tubing while another bad was delivered in order to keep the pump infusing properly.There was no patient injury.

Manufacturer Narrative

Other, other text: on review of the reported event and device, the pre-investigation hazard code was updated for a pca pump.The reportability decision has changed to non-reportable.The event does not meet the definition of a reportable death or serious injury as the malfunction of the device did not cause or contribute to a patient death, a life-threatening event, permanent impairment of a body function or structure, required medical or surgical intervention to preclude serious impairment of a body structure or function.Additionally, the product family hazard analysis indicates that the device in the reported incident would not likely cause or contribute to a death or serious injury if the malfunction were to recur.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SET
• 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; suite 102; minneapolis, MN 55442
• MDR Report Key: 11979035
• MDR Text Key: 255599607
• Report Number: 3012307300-2021-05867
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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