MAUDE Adverse Event Report: ST PAUL CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOWSTOP; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

It was reported, that the cassette was empty 6 hours.Prior to time to change the cassette.The patient complained of headache and stomachache from the drug.No patient injury reported.No further details provided.

Manufacturer Narrative

D5 is unknown.No information has been provided to date.No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.A device history record (dhr) review was conducted, which indicated all inspections were completed.And no issues were noted during manufacture.No product was returned.Therefore, no visual and functional tests were performed.The reported complaint could not be confirmed.And the root cause could not be determined.

Manufacturer Narrative

Other, other text: , corrected data: h10: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD HIGH VOLUME ADMINISTRATION SETS WITH FLOWSTOP
• 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: 17166752
• MDR Text Key: 317573756
• Report Number: 3012307300-2023-06405
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2023
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 66 KG