MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD¿ HIGH-VOLUME ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7081-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter stated that no additional information regarding the event or the patient is available.
Event or Problem Description
It was reported that two hours into infusion, a leakage was observed from a cadd¿ high-volume administration set.The leakage was observed in the pump "where there was the air sensor in the old version of the pump, that is where the infusor is thin".The patient's backpack was drenched and the liquid was spilling out of the set.The "baby" was detached immediately and a new set was placed.No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation in used condition and without its original packaging.Visual inspection of the device found delamination of the solvent bond in the pump tube.Functional testing involved leak testing and found a leak in the pump tube with housing.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on the reported part and found no discrepancies.A sample of 32 devices were visually inspected and did not detect any leaks.Based on the evidence, the root cause was attributed to a manufacturing issue.The most probable root cause was due to the operator not applying sufficient solvent and production personnel did not detect the delamination.

• Brand Name: CADD¿ HIGH-VOLUME ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6776950
• Report Number: 3012307300-2017-01732
• Device Sequence Number: 1444587
• Product Code: FPA
• UDI-Device Identifier: 10610586021480
• UDI-Public: 10610586021480
• Combination Product (Y/N): N
• Initial Reporter Country: MT
• PMA/510(K) Number: K991599
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 21-7081-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CADD® PUMP