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

Device Problems Device Alarm System (1012); Air/Gas in Device (4062)

Patient Problems Diarrhea (1811); Pain (1994); Abdominal Cramps (2543)

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device was not returned for analysis.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.

Event Description

It was reported that a pump's settings were set as ordered by the provider.The patient called in stating that the pump was alarming and there were air bubbles in the tubing.The patient went in to the facility where nursing confirmed settings on the pump appeared correct.This was confirmed by three nurses.The pump indicated 62.45 ml given at continuous rate of 2.4 ml/hour and it stated reservoir volume was 47.3 ml.The bag in the cassette appeared empty and there was air in line.The pump was disconnected.The patient is experiencing adverse side effects, including diarrhea, abdominal cramping leading to hemorrhoid issues resulting in rectal pain/irritation for approximately 5 days.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updates not required.H4: device manufacture date could not be completed due to lack of information regarding lot number.H10: device evaluation: the device was not returned for investigation, so no visual inspection and functional test were performed.Because no product was returned, the investigator was unable to confirm the reported complaint.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.No lot number was provided; therefore, device history record review could not be completed.

• Brand Name: CADD MEDICATION CASSETTE
• 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; minneapolis, MN 55442
• MDR Report Key: 14973642
• MDR Text Key: 303401315
• Report Number: 3012307300-2022-13174
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2022
• 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: 09/13/2022
• 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