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

Catalog Number 21-7322-24

Device Problems Inaccurate Delivery (2339); Priming Problem (4040)

Patient Problems Abdominal Pain (1685); Swelling/ Edema (4577)

Event Date 07/29/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: 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 an under delivery occurred during an albumin infusion using a peripherally inserted central catheter (picc).The mother noticed there was more than normal left in the infusion bag after the infusion.The infusion rate was 140 ml and volume to be infused was 110 ml.The pump appeared normal during priming, however there were issues with the set priming slowly.When the pump stopped priming at 10 ml (the priming volume of the set is much lower), the set was not fully primed and air in line was observed.The reporter stated that during priming, the bag was hanging from a hook, and it was determined air was not coming from the bag.Per the reporter, the patient suffered from nephrotic syndrome.The adverse effects included stomachache and swelling with an increase amount of protein in the urine.

Manufacturer Narrative

Device evaluation: five samples were returned; four in unused conditions and one without original packaging.A visual inspection found no damage or defects on the samples.During the functional testing, all samples successfully passed the delivery accuracy testing within specification.The failure mode was not confirmed.A root cause was not able to be determined as the complaint was not confirmed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• Brand Name: CADD ADMINISTRATION SET
• 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: 17715829
• MDR Text Key: 323064619
• Report Number: 3012307300-2023-08818
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 21-7322-24
• Device Lot Number: 4321322
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic