MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS; PUMP, INFUSION, PCA

Catalog Number 21-2111-0100-51

Device Problem Failure to Infuse (2340)

Patient Problems Bradycardia (1751); Pulmonary Hypertension (4460)

Event Date 05/09/2021

Event Type  malfunction  

Event Description

It was reported that the pump failed to infuse as programmed.Event caused patient to have profound hypotension and bradycardia.It is unknown no medical or surgical intervention was reported.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.No causes or potential causes of the customer's reported problem were found during the review of service and repair record.The tampered seal label was missing.Scratches and cracks found on liquid crystal display (lcd) lens screen: battery door was missing.No evidence found in the device history log.Device passed the functional tests but failed the three accuracy tests.The device was found to over infuse.The reported problem was not confirmed.However, the device was able to infuse however it was over infusing.The root cause of the reported problem could not be confirmed.However, the technician found other problems.The technician recommended expulsor to be trimmed and replaced the air detector for preventive measure.

• Brand Name: CADD SOLIS HPCA PUMPS
• 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: jim vegel
• MDR Report Key: 17019567
• MDR Text Key: 316116793
• Report Number: 3012307300-2023-05822
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170982
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-2111-0100-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male