MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CL3011
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for evaluation, however, it is not yet received.
Event or Problem Description
The event occurred on an unspecified date in may and involved a spinning spiros®, closed male luer.The customer states that they have observed leaks with primary tubing sets and have had 2 issues in the past month along with proximal occlusion alerts on the plum 360.The pumps were tested with no issue but they thought maybe a primary tubing cassette issue or the spiros not luered completely on the mating device.It was unknown if there was patient involvement; harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
Uf/ importer report number (b)(4).Investigation summary received one (1) used cl3011 drop admin set w/integrated chemolock drip chamber, spiros for inspection.No defects or anomalies noted on initial inspection.The set was leak tested per product specifications.There was leakage from the spiros.Examination of the spiros showed a dislodged o-ring.The spiros was disassembled and visually examined and there was no damage on the post of the spiros.The reported complaint can be confirmed.The probable cause of the dislodged o-ring and subsequent leakage is unknown.The device history review for lot 13850282 was reviewed and no relevant non-conformities were found that would have led to the reported complaint.Additional information in b5, d1, d4, d10, h4.
Event or Problem Description
Additional information was received providing the lot number 13850282.The event occurred during patient infusion.No patient harm and slight delay of therapy due to bag had to be remade by pharmacy.Medication leaked from spinning spiros on 2ndary tubing.The medication to be hung was gemzar.The nurse caught it while was just a few drops, most likely was saline that tubing had been primed with, nurse changed out primary tubing first when noticed a problem, then when unclamped secondary tubing, leaking noted at spinning spiros.Bag and tubing taken out of service and pharmacy made a new bag with new tubing.Further information was provided via uf/ importer report number (b)(4) stating that the patient received dose without further problem.The tubing was primed with saline but it is unknown if any chemo leaked out, the pharmacist and nurse surmise since tubing is primed with saline it may have been the saline that leaked.

• Brand Name: 30" (76 CM) APPX 3.3 ML, 20 DROP ADMIN SET W/INTEGRATED CHEMOLOCK¿ DRIP CHAMBER,
• Common Device Name: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19538586
• Report Number: 9617594-2024-00765
• Device Sequence Number: 6081187
• Product Code: ONB
• UDI-Device Identifier: 00887709057012
• UDI-Public: (01)00887709057012(17)281201(10)13850282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: Health Professional
• Device Catalogue Number: CL3011
• Device Lot Number: 13850282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/26/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GEZMAR, MFR UNK.; PLUM 360 PUMP, ICU MEDICAL, INC.; PRIMARY TUBING SET, ICU MEDICAL.
• Patient Sex: Unknown