MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM; PUMP, INFUSION

Model Number 8120

Device Problems Break (1069); Contamination (1120); Corroded (1131); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Device Markings/Labelling Problem (2911); Naturally Worn (2988)

Patient Problem Nausea (1970)

Event Date 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii), the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

Event Description

It was reported that the nurse loaded a syringe with hydromorphone at 17:03.The customers pharmacy orders pre-filled syringed with 31 ml of hydromorphone from an outside vendor.The patient reported feeling "weird" and nauseated while the nurse was still in the room.The nurse noticed that the patient was sleepy and itching and went to check on the patients vitals and then alerted the doctor.The patients vitals were as follow when checked by the nurse: "temp 98.4, hr 68, rr 16, bp 127/63, o2 sat 92%." upon checking the pump module, the nurse noticed that there was only 18 ml of hydromorphone in the 30 ml syringe.The medication was stopped at 17:30 and the pump module was shut down and replaced with another.There was patient involvement but no harm as a result of the event.

Event Description

It was reported that the clinician loaded the syringe containing 31ml of hydromorphone to the pca module at 1703.The medication was programmed to infuse at 1mg/ml (0.25mg/hr.) with volume to be infused (vtbi) 31ml.The customer stated that they receive the syringes prefilled with hydromorphone "from an outside vendor." the syringe's model number and brand were not provided.After an unspecified period, the patient reportedly felt "weird" and nauseated.The clinician, who was in the patient's room, noticed the patient was "sleepy and itching." the clinician checked the vital signs (temperature 98.4 f, heart rate 68, respiratory rate 16, blood pressure 127/63, oxygen saturation 92%) and alerted the physician.Upon checking the pca module, the clinician noticed that there were only 18ml of hydromorphone left.The infusion was then stopped at 1730.The patient required further monitoring but there was no harm.

Manufacturer Narrative

Omit : concomitant med prod data (8015), a1407 - insufficient flow or under infusion (2182), b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Correction : describe event or problem additional information : device eval by manufacturer?, reason code for no evaluation, if other specify, imdrf annex a, b, c, d, g codes and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : not applicable.Device evaluated by bd.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 17763102
• MDR Text Key: 323582079
• Report Number: 2016493-2023-230679
• Device Sequence Number: 1
• Product Code: MEA
• UDI-Device Identifier: 10885403812002
• UDI-Public: (01)10885403812002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 09/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 8120
• Device Catalogue Number: 8120 ALARIS PCA MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015; 8100
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 89 KG