MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIR - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7002-24

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 11/13/2023

Event Type  malfunction  

Manufacturer Narrative

Other, other text: d3, g1,2 email is: regulatory.Responses@icumed.Com.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Event Description

It was reported that during use, the cassette was defective and showing leakage.Per the reporter, it was uncertain of the extent of patient manipulation, and it appeared that the tube at the transition to the cassette bag may have become detached.It was noted that due to the leakage during treatment, the product was contaminated with hydromorphone 2mg/ml.The application was stopped and after filling a new medication reservoir, the therapy was continued immediately.Outcome was resolved.Per the reporter, there were no patient adverse effects.

Manufacturer Narrative

One sample and three photos were received for evaluation.Visual inspection revealed the sample was received used, in a plastic bag in decontaminated conditions.The tube was detached from the cassette, the failure was confirmed.The root cause was determined to be due to manufacturing.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.For all enquiries or follow-up questions related to the record, do not use (b)(4) located in sections g.1., please direct those to the following: (b)(4).

• Brand Name: CADD CASSETTE RESERVOIR - NON FLOW STOP
• 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: reed covert
• MDR Report Key: 18297482
• MDR Text Key: 330133797
• Report Number: 3012307300-2023-10998
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K843772
• 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: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7002-24
• Device Lot Number: 4302530
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/21/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1