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

Model Number 21-7322-24

Device Problems No Audible Prompt/Feedback (2282); Failure to Infuse (2340)

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

Event Type  malfunction  

Event Description

It was reported that when the patient went to fill the medication bag, the medication bag was full, however, the pump said that the residual volume was low.The patient stated that the pump did not beep at all until it hit low residual volume, which is when he noticed that the medication in the bag was never infused.According to the patient the volume of medication left in the bag was approximately 300 milliliters which is the same as the original amount the bag was filled with.No patient injury was reported.

Manufacturer Narrative

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 reportable information becomes available.

Manufacturer Narrative

Other, other text: b5: describe event or problem: updated with additional information received.H6: event problem and evaluation codes: updates are not required.H10: no sample has been received by manufacturing to date.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 reportable information becomes available., corrected data: h3: correction: device evaluated by manufacturer: device not returned to manufacturer.

Event Description

Additional information was received by the manufacturer on (b)(6)-2022 via email and attached to the complaint object.The pump logs are available for ten separate files.The pump will not be returning as it appears to be a tubing issue only.(b)(4) sets of lot 4290730 are available for return.The reported issue occurred while in use with the patient.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.H10: device evaluation: the samples were returned for investigation.The returned samples were received in used conditions without their original packaging, decontaminated and inside in a plastic bag.The complaint returned unit was visually inspected under normal conditions of illumination.No damage, kinks, cut, or deformations were observed in the unit returned that could cause the failure mode reported.The sample was set for accuracy testing; samples 1 and 4 passed, samples 2 and 3 failed.No discrepancies were detected on the sample the test successfully passed.The samples were tested to measure the height of the pump tube arch and determine if they were under or out of spec; the samples failed the arch height tube measure test.The failure mode reported was confirmed.Capa-000903 was opened to investigate the under-delivery/ non-delivery issue reported.The root cause investigation identified flow stop feature differences between arm occlusion molded parts as the major cause factor.Corrective actions were taken based on capa above.The cause of the reported issue was traced to the supplier.A dhr (device history review) was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SET WITH 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; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; suite 10; minneapolis, MN 55442
• MDR Report Key: 15972325
• MDR Text Key: 308075103
• Report Number: 3012307300-2022-27841
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 30610586029640
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7322-24
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 81 KG