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

Device Problems Volume Accuracy Problem (1675); Connection Problem (2900)

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

Event Date 04/27/2022

Event Type  malfunction  

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

Event Description

It was reported that a "no disposable error" alarm occurred with 12.6ml remaining, but the cassette was empty.Patient had a pump finish early 2 weeks ago per rn addressing early pump finish at site.No patient injury was reported.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: customer sends lot number of the tubing but it is invalid.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14602622
• MDR Text Key: 293358139
• Report Number: 3012307300-2022-10775
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/06/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White