MAUDE Adverse Event Report: NULL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Product Quality Problem (1506)

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

Event Date 06/13/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: updated b17, c20, d14 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.Device evaluation: one photo was provided by the customer which was used to conduct the device analysis since the physical unit, by the time this investigation is being documented, has not been received in the tijuana site.Results: the photo shows a male luer connector end were the tube is observed to be kinked and have air bubbles, this connector is not part of cadd cassettes.The reported failure mode, no disposable alarm - pump won't run, is not confirmed.Functional testing: no product has been received to conduct a functional test.Results: if the device arrives, icu will reopen this complaint to include in the investigation the physical sample returned.After reviewing the mitigations that are performed during the manufacturing process to detect pump alarms, and analyzing the photo provided, the root cause cannot be determined.Action taken no corrective actions are required because the mitigations on place were revised and are being executed as is determined by procedure.This failure will continue to be monitored to determine if new actions need to be taken.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No product was returned.We are unable to confirm the reported complaint.If the product is returned, icu 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.

Event Description

It was reported the disposable caused the pump to alarm? no disposable pump won't run.Air noted in tubing.No patient injury.

Manufacturer Narrative

Device evaluation: one photo of the cassette was provided by the customer.The photos shows a male luer connector end were the tube is observed to be kinked and have air bubbles, this connector is not part of cassettes.The reported failure mode, no disposable alarm, pump won't run, is not confirmed.No product has been received to conduct a functional test.If the device arrives, icu will reopen this complaint to include in the investigation the physical sample returned.After reviewing the mitigations that are performed during the manufacturing process to detect pump alarms, and analyzing the photo provided, the root cause cannot be determined.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 17229725
• MDR Text Key: 318134320
• Report Number: 3012307300-2023-06880
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• 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