MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 60" (152 CM) APPX 1.8 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP (BLU; STOPCOCK, I.V. SET

Model Number	MC33563
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 60" (152 cm) appx 1.8 ml, smallbore ext set w/remv microclave® clear, clamp (blue), luer lock.The reporter stated a patient's manifold was primed in the operating room with the substitution tubing and the clear caps were removed off each of the lines.The tubing is 1.8 and bigger than the continuous tubing they usually use for manifolds.The bedside nurse stated there was blood backing up into the manifold.After trying to trouble shoot the pumps and increasing the carrier to 5ml/hr to attempt to clear the line, the nurse ultimately had to disconnect the line closest to the patient to assess if the line was clotted.Once she disconnected the line a lot of fluid expelled from the manifold.The bedside nurse was instructed to push the normal saline carrier through the manifold to clear the blood.After she stopped putting pressure on the back of the syringe, the manifold sucked in air.Staff has had issues with this substitute tubing backing up air after pressure is released from the back of the syringe.Ultimately they were able to clear the manifold and line with continuous pressure on all of the syringes.The patient was on epinephrine at 0.04, amiodarone and milrinone, because they had to interrupt the stead state, they had to increase her drips and call the intensivist to bedside due to her hypotension.Due to this issue the bedside nurse ended up priming a whole new manifold with the continuous tubing we usually use for manifolds.The affected product was not saved.There was patient involvement and no report of patient harm.
Event or Problem Description
Additional information was received by the customer stating that blood was backing up through the entire manifold, all the way to the tubing of all the continuous infusions.The bedside nurse completely primed all new continuous drips and a manifold and changed it out.Once it was all changed out there were no more issues reported.
Additional Manufacturer Narrative
The dhr for lot 5955011 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Additional information in b5 and h6.

• Brand Name: 60" (152 CM) APPX 1.8 ML, SMALLBORE EXT SET W/REMV MICROCLAVE® CLEAR, CLAMP (BLU
• Common Device Name: STOPCOCK, I.V. SET
• 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: 15348387
• Report Number: 9617594-2022-00251
• Device Sequence Number: 4922017
• Product Code: FMG
• UDI-Device Identifier: 00887709057838
• UDI-Public: (01)00887709057838(17)270501(10)5955011
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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 Model Number: MC33563
• Device Catalogue Number: MC33563
• Device Lot Number: 5955011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2022
• 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: AMIODARONE, UNK MFR.; EPINEPHRINE, UNK MFR.; MANIFOLD, UNK MFR.; MILRINONE, UNK MFR.; NORMAL SALINE, UNK MFR.; UNSPECIFIED INFUSION PUMP, UNK MFR.
• Patient Sex: Female