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  

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

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

One photo and four samples were received for evaluation.Visual inspection revealed no anomalies.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No actions were taken.For all enquires or follow up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in section g2, please direct those to the following: regulatory.Responses@icumed.Com.

• 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: 17715425
• MDR Text Key: 323011298
• Report Number: 3012307300-2023-08807
• 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: 03/22/2024

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?: Device Returned to Manufacturer
• 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?: Yes
• Date Device Manufactured: 10/05/2022
• 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
• Patient Race: White