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

Model Number 21-7302-24

Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

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

Event Date 06/03/2021

Event Type  malfunction  

Event Description

It was reported that.After a while when the customer turned on the pump with medical fluid filled in the cassette, an occlusion alarm sounded and medical fluid was not administered to the patient.The customer thought there was a problem in the pump and he changed it to another one.However, the occlusion alarm was issued again.No patient injury was reported.

Manufacturer Narrative

Other, other text: this mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No problems or issues were identified during this device history record review.Three (3) pictures were attached.Picture one showed a cassette product outside of its original packaging, cassette.Picture two showed the pump tube of a cassette product.Picture three showed the top view of a cassette product.The sample consist of one cassette.Sample was received in used conditions without its original packaging and decontaminated.The sample was visually inspected at a distance of 12 to 16 inches under normal conditions of illumination to detect samples conditions that could cause functional issues.The sample didn?t present any damage, scuffs, pinch marks, cracks, crazing, etc.That could cause the failure mode reported.The complaint was not confirmed due to sample was tested and no alarms were activated.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.Per trend review in no disposable alarm code an escalation to investigate this failure was initiated on march 08, 2021 under n on conformity report ncr.No actions taken were performed since the complaint was not confirmed.

• Brand Name: CADD CASSETTE RESERVOIRS - 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: jim vegel
• MDR Report Key: 16853737
• MDR Text Key: 314532714
• Report Number: 3012307300-2023-04873
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4052410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Race: Asian