MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET WITH MICROBORE TUBING, EXTENSI; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7052-24

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Operator of device: patient/consumer.No device has been returned to date.

Event Description

It was reported that a pump showed an error message and alarm for downstream occlusion.This happened ten times with different sets each time.The 10 sets came from the same lot.All had the same fault but the eleventh set worked.No patient injury was reported.

Manufacturer Narrative

Additional information received by smiths medical/icu on 08-jun-2022 via email and attached to complaint object: patient details updated in complaint.New pump and extension sets sent to the patient.

Manufacturer Narrative

H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: CADD EXTENSION SET WITH MICROBORE TUBING, EXTENSI
• 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; centrum 100; minneapolis, MN 55442
• MDR Report Key: 14602510
• MDR Text Key: 293358715
• Report Number: 3012307300-2022-10772
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Device Lot Number: 4189960
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female