MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. DIANA CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	CH4000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified date in (b)(6) 2022 and involved a diana cassette that the customer reported after preparation of infusers the outer silicone strip on the spiros breaks.The event occurred during preparation of the cytotoxic medication called fluoro-uracil using the diana pump.The product was in use for 30 minutes and once it started to leak, the device was changed out/replaced with no further problems encountered.There was no patient involvement, no patient harm, no delay in critical therapy.However, there was unprotected chemotherapy exposure to the healthcare provider that was wearing ppe.There was no serious injury/death, no blood loss and no medical/ surgical intervention required.This captures the first of five events.
Additional Manufacturer Narrative
Received one used list #ch4000, diana cassette (lot #5628159) and it was visually inspected.As received, the strap of one spiros was broken and torn.No additional damage or anomalies were identified.No mating devices were returned.The reported complaint can be confirmed on the one sample returned.The probable cause of the strap damage is due to an error during assembly.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Additional Manufacturer Narrative
Updated investigation states that the probable cause of the broken strap is unknown.

• Brand Name: DIANA CASSETTE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 14176278
• Report Number: 9617594-2022-00085
• Device Sequence Number: 6254016
• Product Code: FPA
• UDI-Device Identifier: 00840619053222
• UDI-Public: (01)00840619053222(17)241001(10)5628159
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: Health Professional
• Device Expiration Date: 10/01/2024
• Device Model Number: CH4000
• Device Catalogue Number: CH4000
• Device Lot Number: 5628159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FLUORO-URACIL, MFR UNK; SYRINGE, MFR BECTON DICKINSON, LN 300629
• Patient Sex: Unknown