MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK; STOPCOCK, I.V. SET

Model Number B90051

Device Problems Obstruction of Flow (2423); No Flow (2991)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 10/01/2022

Event Type  Injury  

Manufacturer Narrative

The device was returned for evaluation.However; testing has not yet been completed.

Event Description

The event occurred on an unspecified date and involved a 9" smallbore ext set w/0.2 micron filter, clave®, clamp, check valve w/luer lock.It was reported that a 0.2 micron iv air filter clogged when an infusion was going overnight, leading to the patient decompensating and requiring interventions to keep their blood pressure pressures stable.It was stated that the blood pressure before the event was 81/32 mean 50, during event 42/13, with saturations dropping from 76% to 40%.Blood pressure recovered to pre-event status after filter removed and the following interventions: iv pumps beeped occluded, filter removed, and drips reconnected.Patient was on epinephrine, vasopressin, dilaudid, precedex and tpn.Additionally, patient received iv fluid bolus, diluted epi dose, extra sedation and paralytic.The reported clinical events were life-threatening and intervention was required to preclude permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

Received four (4) used b90051 extension sets for inspection.Fluid residuals observed in all sets.The filter was oriented in the wrong direction on sample 1.Each set was primed per packaging directions.The sets were unable to flow at gravity pressure.Pressure was increased till fluid was able to flow through the filter.Leakage was observed from the filter vents.The reported complaint can be confirmed on the returned four (4) used b90051 extension sets.The probable cause is due to infusate clogging the filters.The dfu states: "filters should be changed at least every 72-hours.A filter that clogs during infusion should be replaced." the probable cause of the wrong orientation of the filter on the one (1) used b90051 extension set is due to an assembly error in ensenada.The manufacturer of the filter states: "after priming is complete speedflow filter can stay any position." the filter being assembled in the opposite direction does not affect the functionality of the device.A device history record could not be reviewed because no lot number(s) was/were identified.Additional information update in b5.

Event Description

An update was provided stating that the infusion had been going for at least a day but it was unclear exactly how long.They changed the tubing and filter at the 96 hour mark as recommended by guidelines.It was also stated that she was not sure if the sample they had sent were from this incident specifically or from subsequent issues.Furthermore, the infusion would have been running together and compatibility was checked.The bolus, diluted epi and extra sedation and paralytic would have been infused separately in a different line.

• Brand Name: 9" SMALLBORE EXT SET W/0.2 MICRON FILTER, CLAVE®, CLAMP, CHECK VALVE W/LUER LOCK
• Type of Device: 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: 15785512
• MDR Text Key: 303566947
• Report Number: 9617594-2022-00301
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B90051
• Device Catalogue Number: B90051
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2022
• Initial Date FDA Received: 11/11/2022
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DILAUDID, MFR UNK; EPINEPHRINE, MFR UNK; PRECEDEX, MFR UNK; TOTAL PARENTERAL NUTRITION, MFR UNK; VASOPRESSIN, MFR UNK
• Patient Outcome(s): Life Threatening