MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7391-24

Device Problem Inaccurate Delivery (2339)

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

Event Date 04/05/2023

Event Type  malfunction  

Event Description

It was reported that the product was under infusing, does not pass accuracy test; uncertain of the cause.No patient involvement reported.

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other, other text: test details and photo attached to complaint.The pump was indeed tested with the admin sets provided.The users had noticed that after infusion too much fluid was left in the bag.This indicated possible under-infusion and the pump (complete with admin set) was handed over for investigation.They were tested for delivery accuracy and found that it was slightly out of tolerance, delivering a little less than it should.This could be caused by an issue with giving sets (not so likely the pump) and requested that pump and giving sets be sent in for investigation.It is not likely there is any problem with the pump.However, it is possible that the admin sets are not within tolerance.This is what needs to be determined.

Manufacturer Narrative

Other, other text: one device was received for evaluation.Visual inspection found no damage or other defects on the sample.An accuracy test was performed to conduct functional testing.Upon review, the reported problem was unable to be duplicated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D3, g1,g2 email is: regulatory.Responses@icumed.Com, a1 updated.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16812349
• MDR Text Key: 314003625
• Report Number: 3012307300-2023-04562
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: 10610586027512
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7391-24
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 4315953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1