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

Model Number	21-7091-24
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the product was under infusing, does not pass accuracy test; it is uncertain of the cause.No patient involvement reported.
Additional Manufacturer Narrative
Test details and photo attached to complaint.The device 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 device (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 device and giving sets be sent in for investigation.It is not likely there is any problem with the device.However, it is possible that the admin sets are not within tolerance.This is what needs to be determined.
Additional Manufacturer Narrative
Other, other text: one disposable was received for evaluation.Visual inspection found sticky stains on the tubing sections, no other damage or defects were observed.Functional testing was conducted.Upon review, the reported problem was unable to confirm or duplicate the reported problem.No serial number was provided; therefore, a device history record (dhr) review could not be conducted.D3, g1,g2 email is: regulatory.Responses@icumed.Com.

• Brand Name: CADD CHECKVALVE ADMINISTRATION SET
• Common Device Name: 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: 16812277
• Report Number: 3012307300-2023-04561
• Device Sequence Number: 17576123
• Product Code: FPA
• UDI-Device Identifier: 10610586024160
• UDI-Public: 10610586024160
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/23/2024

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
• Operator of Device: Other
• Device Model Number: 21-7091-24
• Device Catalogue Number: 21-7091-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 10/09/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 05/30/2023; 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown