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

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

Operator of device: patient/consumer.No additional information has been received to date.No product has been returned to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that, during priming with a new cassette, the pump was alarming high pressure, which may have been due to a kink in the fluid path.The tubing was changed out, the issue resolved, and infusion continued.No patient injury was reported.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: no product or photographic evidence was 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, the complaint will be reopened for further investigation.No lot or serial number was provided therefore, a device history record dhr review could not be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.

• Brand Name: CADD ADMIN SETS
• 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: jim vegel ; 6000 nathan lane north; 105 mall blvd; minneapolis, MN 55442
• MDR Report Key: 14973651
• MDR Text Key: 303952818
• Report Number: 3012307300-2022-13183
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2023
• 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
• Patient Sequence Number: 1