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

Model Number 21-2111-0300-01

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the pump has an unknown issue.No adverse patient effects were reported by the customer.

Manufacturer Narrative

Other, other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: b3: date of event is unknown, no information has been provided to date.Device evaluation: one device was returned for investigation.The tamper seal was not removed or broken.Visual inspection noted the device was used and decontaminated.Device did not come in original box.Physical condition of the device note a lifting down stream occlusion (dso) sensor.Review of the event history/error log found "6/9/2023 4:49:16 pm high alarm displayed: cassette not attached properly 5/17/2023 and 5:48:44 pm high alarm displayed: downstream occlusion".The complaint was confirmed.Both reported problems "cassette" and "downstream occlusion" were duplicated.Performed calibration to test downstream, which failed.Inserted cassette to device and "cassette not attached properly" alarmed.Root cause was attributed to an inoperable dso sensor.What caused the dso sensor to be inoperable was not determined.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.

• 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: 17368331
• MDR Text Key: 319486339
• Report Number: 3012307300-2023-07433
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10610586038778
• UDI-Public: 10610586038778
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130394
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-2111-0300-01
• Device Catalogue Number: 21-2111-0300-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1