MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 12" (30 CM) EXT SET W/MICROCLAVE®, 0.2 MICRON LOW PROTEIN BINDING FILTER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number	CH3531
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Icu medical received an email on from representative of (b)(6) hospital regarding a 12" (30 cm) ext set w/microclave®, 0.2 micron low protein binding filter, 2 clamps, spiros® w/red cap resulted in no flow of infusion.The report stated that patient was running atg with filter, 4 hours into 6-hour infusion pump alarmed patient side occlusion, registered nurse (rn) flushed at clave, flushed with no issues, but pump kept beeping patient side occluded.Not a pump issue, rn spoke with nurse practitioner and pharmacist about waste amount of filter (5 mls), negligible amount based on dose per pharmacist.Rn changed out spiros filter for regular 0.2-micron filter without spiros.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device is expected to be returned, however it has not yet been received.Upon receiving the device a device evaluation is expected to be performed.
Additional Manufacturer Narrative
Additional information: medwatch report# (b)(4).Patient information - 4 year old female.Investigation summary received one (1) used ch3531 ext set w/ microclave for inspection.No defects or anomalies noted.The set was primed at gravity pressure.The reported complaint was unable to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 12" (30 CM) EXT SET W/MICROCLAVE®, 0.2 MICRON LOW PROTEIN BINDING FILTER
• 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; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 19332141
• Report Number: 9617594-2024-00611
• Device Sequence Number: 16913274
• Product Code: ONB
• UDI-Device Identifier: 00887709074057
• UDI-Public: (01)00887709074057(17)260201(10)5180666
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/08/2024

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 Expiration Date: 02/01/2026
• Device Catalogue Number: CH3531
• Device Lot Number: 5180666
• 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: 05/10/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2021
• 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: ANTI-THYMOCYTE GLOBULIN, MFR UNK
• Patient Age: 4 YR
• Patient Sex: Female