MAUDE Adverse Event Report: CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASC

Catalog Number 21-7322-24

Device Problem Volume Accuracy Problem (1675)

Patient Problems No Patient Involvement (2645); No Information (3190)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd disposable set displayed volume accuracy issues.Different sets were tried, producing difference results.There were no adverse events reported.

Event Description

Additional information was received indicating the event occurred during annual testing.It was specified that the cadd administration set under-delivered and there was no patient involvement.

Manufacturer Narrative

H2: see a1, b5, d4, h4 and h6(patient code).

Manufacturer Narrative

Four cadd administration sets from p/n 21-7322-24 one from l/n 3765250, one from l/n 3931737 and two from l/n 3886096 were received in used conditions inside a plastic bag with their original packaging open the samples were visually inspected at a distance of 12" to 16" under normal conditions of illumination.All the samples were received numbered from 1 to 4; sample #1 correspond to l/n 3765250, sample #2 correspond to l/n 3931737 and samples #3 and #4 correspond to l/n 3886096.A kink was detected on the pump tube of the four samples caused by the ffp system since that they were returned without the blue clip, the arch height pump tube was too low almost flat; also sample #2 and #4 had the pump tube misaligned.The samples were set for accuracy testing using a pump solis vip and a balance mettler toledo.The functional test could not be performed on samples 1, 2 and 3 due to the fact that the kink detected did not allow the fluid to pass; only sample 4 could be primed and submitted to the test.No discrepancies were detected; sample passed the test.Relevant documents which were reviewed and deemed adequate and correct with respect to testing and inspection activities.Since the reported issue is a known problem, based on visual inspection of the samples, the most probable cause is that the pump tube arch height is too low.There was no fault found with the returned administration set.

• Brand Name: CADD EXTENSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASC
• MDR Report Key: 9983208
• MDR Text Key: 188405909
• Report Number: 3012307300-2020-03366
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 21-7322-24
• Device Lot Number: 3886096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1