MAUDE Adverse Event Report: ST PAUL REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7094-24

Device Problems Device Alarm System (1012); Increase in Pressure (1491)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Information was received indicating nine cadd administration sets constantly showed overpressure on the pump, all error messages were checked, and the error message could not be resolved.It was reported the end user replaced the lines with no change, after changing the disposable to a different administration set the unit no longer displayed an error message.

Manufacturer Narrative

Report source: (b)(6).

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received indicating nine cadd administration sets constantly showed overpressure on the pump, all error messages were checked, and the error message could not be resolved.It was reported the end user replaced the lines with no change, after changing the disposable to a different administration set the unit no longer displayed an error message.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection: no occlusions nor other workmanship defects were detected in none of the joins of the sample.Functional test: the sample received was connected to prime using a cadd pump legacy.Sample was set to pump and an alarm was show on display during the prime and it cannot be possible; thus, the failure mode is confirmed.Based on the analysis conducted in the sample provided, suction line occluded failure mode was confirmed.Therefore, according pfmea the occurrence of this failure condition could be caused by: too much solvent accumulated when dipped in fixture; held in fixture too long.The cause of the reported problem was traced to the manufacturing process.Any relevant dmrs, ncrs, ets analysis revealed there were no issues, nonconformances reported during the manufacture of this lot.

• Brand Name: REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
• 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: 13590300
• MDR Text Key: 286050493
• Report Number: 3012307300-2022-04071
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K933390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7094-24
• Device Catalogue Number: 21-7094-24
• Device Lot Number: 4048931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1