MAUDE Adverse Event Report: ST PAUL; PUMP, INFUSION

Device Problems Device Alarm System (1012); Increase in Pressure (1491)

Patient Problems Diarrhea (1811); Swelling/ Edema (4577)

Event Date 02/22/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that the patient was mixing new cassette but pump kept alerting for high pressure during priming.Daughter stated she tried to troubleshoot by disconnecting and reconnecting, turning off and on pump but unable to resolve; patient's daughter stated.Mixed a new cassette and had no further issues.Patient daughter stated patient was still connected to old.Pump and cassette so patient did not stop infusing and had no gaps in therapy; patient stated she does not have serial number of cassette as she had already thrown the malfunctioned cassette away; advised for future to hold on to any malfunctioned cassettes; daughter also mentioned that patient experiencing an increase in diarrhea, swelling.And has been noticing some diminished taste; discussed side effects of medication and when to seek medical attention; advised f/u with mdo as well; patient daughter verbally understood; patient uses iv remodulin with pump.No other information known.The reported product fault did not occur while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.The actual cassette is not available for investigation.The manufacturer replaces the device.Patient they were able to switch to and was able to successfully continue their infusion.The infusion is life sustaining.The outcome of the event was resolved.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be the dso sensor, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.D4: model number, catalog number, serial number, udi, g5, and h4 are unknown.

• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16637569
• MDR Text Key: 312294802
• Report Number: 3012307300-2023-03208
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/21/2023
• 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
• Patient Age: 72 YR
• Patient Sex: Female