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

Catalog Number	CH4000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and pending investigation.
Event or Problem Description
The customer reported that diana cassette experienced a leak of fluorouracil.There was no information about patient involvement, adverse event or medical intervention.The event occurred on an unknown date.
Additional Manufacturer Narrative
H10: a used sample was returned for investigation.There was no visual damage or anomalies observed with the returned device.The device was pressure leak tested and was found to be leaking.The leakage was isolated to the outlet port spiros, and subsequent disassembly revealed an o-ring with pitting.The complaint was confirmed.The probable cause is leakage due to an o-ring with pitting that was molded during manufacturing process.The lot reviews were performed with no issues noted.

• 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
• MDR Report Key: 8697816
• Report Number: 9617594-2019-00176
• Device Sequence Number: 1889501
• Product Code: FPA
• UDI-Device Identifier: 00840619053222
• UDI-Public: (01)00840619053222(17)211001(10)3805003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 10/01/2021
• Device Catalogue Number: CH4000
• Device Lot Number: 3805003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2019
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/09/2019
• 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: FLUOROURACIL.