MAUDE Adverse Event Report: ST PAUL CADD-SOLIS AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Device Problems Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

Patient Problems Fall (1848); Hypoglycemia (1912)

Event Type  malfunction  

Event Description

It was reported that during use, the pump exhibited delivery accuracy issues.Per the reporter, the patient's infusion would end on the screen read 0.8ml in red, running in green, taper down, and infusion complete in 29 min.It was noted that there was still fluid in the bag but the pump showed that infusion was complete despite having 29 minutes left; this varied from 25-31 minutes, but every day infusion ended early.An additional 100 ml of overfill (total 200ml) was added to the bag which helped the bag to run dry.It was stated that then there was volume left in the bag most days, the pump would just end approximately 30 minutes early.Initially the patient did not report this as they felt fine.It was also reported that about once per week, the bag would run completely dry.The pump did not alarm and appeared to still be running.Per the reporter, the patient experienced some low blood sugar had a fall as a result.No intervention or treatment was necessary.The pump was exchanged.Programming settings were: infusion volume 2800ml, taper up/down 1 hour, infusion duration 22 hours, plateau rate 133.4ml/hour, kvo 5ml/hour.

Manufacturer Narrative

Other, other text: d3, g1,2 email is: (b)(4).B3: event date unknown.D4: model, catalog, serial, udi number unavailable.G5: 510k number unavailable.H4: device manufacture date unavailable.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 information becomes available.

Manufacturer Narrative

No product was returned.The investigation determined the most probable cause to be due to the expulsor, 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.G1, email address: (b)(6).

• Brand Name: CADD-SOLIS AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18321106
• MDR Text Key: 330949841
• Report Number: 3012307300-2023-11031
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2024
• 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