MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMPS - 2110; PUMP, INFUSION, PCA

Catalog Number 21-2111-0100-50

Device Problems Device Alarm System (1012); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

Other, other text: b3: date of event is unknown; d4: udi number is unknown; g5: 510k is unknown; no information has been provided to date.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 the device has a faulty cassette latch and alarming fault 42224.It is unknown if there was patient involvement and no adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: one device was returned for analysis.Visual inspection showed a cracked battery door and compartment, scratched lens, and the dso seal was coming off.The device showed liquid residues.The tamper seal was missing.There was no evidence to review in the device's event history log.A visual inspection and functional test were performed and the reported issue of the faulty latch issue was not duplicated, however error 42224 was duplicated.The caused of the reported issue was unknown.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.

• Brand Name: CADD SOLIS HPCA PUMPS - 2110
• 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: 17453438
• MDR Text Key: 320541771
• Report Number: 3012307300-2023-07778
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-2111-0100-50
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/11/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1