MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD¿ MEDICATION CASSETTE RESERVOIR WITH CLAMP AND FEMALE LUER; PUMP, INFUSION

Catalog Number 21-7001-24

Device Problems Device Alarm System (1012); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

Please see mfr #'s 3012307300-2018-01874 and 3012307300-2018-01878 for related device incidents.

Event Description

It was reported that a medication cassette reservoir may have caused two ambulatory infusion pumps to elicit a false "no disposable, clamp tubing" alarm while a patient was receiving chemotherapy.The first alarm happened while the patient was at home and chemotherapy was supposed to finish in 48 hours but the pump alarmed.Patient had to return to the clinic the next day upon which the pharmacist changed to another pump and kept the patient in the clinic to observe the infusion.The same alarm happened again after a few hours and the rest of the chemo drugs had to be purged to the patient using a third pump.The clinic's biomedical engineer tested both pumps and found them to be functioning properly and suspected that the medication cassette may have been defective.No patient or clinical injury was associated with this incident.

Manufacturer Narrative

Evaluation results: a cadd cassette reservoir, and an extension set, were returned for investigation in used condition.The cassette was visually inspected at a distance of 12 to 24 inches under normal conditions of illumination.No abnormalities were observed.The extension set was received in an occluded state.The occlusion was from dried medication in the outlet side of the filter.The returned cassette was functionally tested using a cadd legacy plus pump in order to look for any unusual functions.The cassette was fully priming and connected without difficulty.The pump was ran, and the alarm was not activated.A root cause could not be determined for this product problem because the complaint was not confirmed.The returned extension set could not be functionally tested because they were received in a state that did not allow for priming.

• Brand Name: CADD¿ MEDICATION CASSETTE RESERVOIR WITH CLAMP AND FEMALE LUER
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7570733
• MDR Text Key: 110172307
• Report Number: 3012307300-2018-01875
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10610586022111
• UDI-Public: 10610586022111
• Combination Product (y/n): N
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2022
• Device Catalogue Number: 21-7001-24
• Device Lot Number: 17X474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1