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

Model Number 21-7052-24

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Operator of device is patient/consumer.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 the pump had faulty extension lines and there was a kink in the line.No patient injury was reported.

Manufacturer Narrative

Other text: b5: additional information received by smiths medical/icu on 17-jun-2022 via email and attached to complaint object: date of the event updated from unknown to 19-may-22.Patient details updated in complaint.Product issue did not cause or contribute to patient or clinical injury.Patient received an error message while using the extension sets downstream occlusion.Outcome of the event is ongoing.New pump and extension sets provided to patient.Unknown whether patient received medical treatment.Approximate time of event: 13.30.

Manufacturer Narrative

The affected item was updated from the investigation notes with the item number (21-7052-24) and the lot number (4189960).H6: event problem and evaluation codes: updates not required.The device was not returned for investigation, so no visual inspection and functional test were performed.Based on the fact that no product was returned, the investigator was unable to confirm the reported complaint.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

Manufacturer Narrative

Other, other text: b5: the affected item was updated from the investigation notes with the item number (21-7052-24) and the lot number (4189960).H6: event problem and evaluation codes: updates not required.H3: device evaluated by manufacturer: updated.H10:the device was not returned for investigation, so no visual inspection and functional test were performed.Based on the fact that no product was returned, the investigator was unable to confirm the reported complaint.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available., corrected data: d1: brand name; d2: product code; d2: common device name; d3: manufacturer name; d4: udi#; d4: device expiration date; h4: device manufacturing date.

• 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; centrum 100; minneapolis, MN 55442
• MDR Report Key: 14606058
• MDR Text Key: 293449708
• Report Number: 3012307300-2022-10863
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2022

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: Lay User/Patient
• Device Model Number: 21-7052-24
• Device Catalogue Number: 21-7052-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 06/17/2022; 09/09/2022; 09/09/2022
• Supplement Dates FDA Received: 07/12/2022; 09/29/2022; 10/04/2022
• 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 Age: 57 YR
• Patient Sex: Female