MAUDE Adverse Event Report: ST PAUL; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Device Alarm System (1012); Device Sensing Problem (2917); Priming Problem (4040)

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

Event Date 05/16/2022

Event Type  malfunction  

Event Description

It was reported that the cassette will not prime on either pump, is not sensed on either pump and received no disposable alarms on both pumps.No patient injury was reported.

Manufacturer Narrative

A device history record (dhr) review was not conducted, based upon review of the information provided by the customer, as it does not indicate a problem with the initial manufacture or prior repair of the device.No product device was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product device was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Brand name, model #, serial #, expiration date, catalog #, lot #, other #, udi #, and if ind/preanda, give protocol # are unknown.No product information has been provided to date.Operator of device is patient/consumer.Initial reporter also sent report to fda is unknown.No information has been provided to date.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14632802
• MDR Text Key: 293549312
• Report Number: 3012307300-2022-11129
• 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: Nurse
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1