MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7343-24
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 or Problem Description
It was reported that the device exhibited an air in line alarm even if there was no air in the pipe.Per reporter the alarm could not be rectified by any means.The device was also replaced but the problem persisted.The reporter further noted that there were no problems with the device, the problem was solved by replacing the administration sets.The event occurred during infusion at the patient's home.There was unknown patient involvement, and no patient harm reported.
Event or Problem Description
Gcm received an email on 3-sept-2024 from dr.(b)(6), pharmacist, quality assurance manager at (b)(6) regarding a set, admin, cadd, 114", spike, 1.2 fltr, nac, fs, totm  15/bx lot number 4426873 and item number 21-7343-24.The following issue was stated: 'the pump gives an air alarm even if there is no air in the pipe.The alarm could not be rectified by any means.The pump was also replaced and the problem persists.2 lot numbers are affected: 4448943 and 4426873.Unfortunately, the affected lines have already been removed, but i have received a total of 13 lines from the two lots that are still in the original packaging.They are available for examination.' the client asked for a replacement.There was unknown patient involvement.(b)(6) 4-sept-2024 update: gcm received an email from (b)(6), pharmacist, quality assurance manager at (b)(6), with the pick-up details.She stated that she will be back with an email with the additional information about the event as soon as she has the answers.(b)(6) 5-sept-2024 update: gcm received an email from (b)(6) on 11-sept-2024 with the following information: there are no problems with the pump, the problem was actually solved by replacing the admin sets.She has forwarded the other questions to the colleagues on site who look after the patients, and (b)(6) will be back with an email as soon as she receives the answers.(b)(6) 11-sept-2024 update: gcm received an email on 19-sept-2024 from (b)(6) with the following information: she didn't receive any answer regarding the questions for additional information.She asked her colleague again and will be back with an answer after she receives one.(b)(6) 19-sept-2024 update: gcm received an email on 19-sept-2024 from (b)(6) , pharmacist - quality assurance manager pharmacovigilance at (b)(6), with the following information: the date of the incident is (b)(6) 2024, the event has occurred during infusion at the patient's home.The user was the patient, but the infusion was given by the carer.The patient details (postcode, city) are: (b)(6).The patient was not harmed during the event.(b)(6) 19-sept-2024.
Additional Manufacturer Narrative
Three samples were received in used condition for evaluation.No damage or other defects were detected on the samples.Device history review showed no relevant findings.The failure mode a0095-causes pump to alarm was not confirmed.Retrospective review found no complaints related to same failure mode or same lot number reported.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20332937
• Report Number: 3012307300-2024-10224
• Device Sequence Number: 9727917
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: (01)15019517191820(17)280923(10)4426873
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7343-24
• Device Lot Number: 4426873
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/27/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 12/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown