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Model Number 2426-0500
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Sedation (2368); Lethargy (2560)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, lot: y306845, exp: nov20, 0. 9% nacl injection; 100ml baxter bag, lot: p397216, exp: mar21, hydromorphone in 0. 9% sodium chloride. The customer¿s report of a hydromorphone over infusion was confirmed after a review of the event logs. A failed check valve on the primary set was also identified during the investigation log analysis results identified the time of the incident occurring between 4:36 am and 6:08 am on (b)(6) 2019. During this time frame the secondary infusion was programmed at a rate of 3ml/h and is suspected to have been the hydromorphone infusion. The infusion was stopped at 4:38 am when the user updated the vtbi to 999ml on the primary infusion. Once the update was completed the user started the infusion at a rate of 100ml/h. In this situation, unless the secondary roller clamp was closed hydromorphone would infuse with the new primary infusion rate of 100ml/h instead of the 3ml/h. At a rate of 100ml/h, the secondary bag consisting of 100mls will completely deplete in one hour. The over infusion test method consisting of back flow testing identified a check valve failure with the primary set suspected to have contributed to a perceived over infusion. Rate accuracy testing found the device to be in specification. During testing there were no instances of unregulated flow observed in the primary set¿s drip chamber. The proximate cause of the customer¿s report of an over infusion of hydromorphone was attributed to a user programming error. A failed check valve on the primary set identified during the investigation may have also contributed to a perceived over infusion by the customer.
Event Description
It was reported there was an over infusion of hydromorphone. The patient received 50 mg of hydromorphone over a two hour period. The pharmacist contacted the provider to ask if the pca only infusion could be changed to a drip so the nurse would not have to change the hydromorphone pca every two hours. The provider agreed to the drip and the pharmacist changed the order. It was reported that the device delivering the medication was changed from a pca module to a pump module for administration. The ordered dose of hydromorphone was 1. 5mg/hr with an ordered rate of 3ml/hr. The concentration of the drug was 0. 5mg/1ml. Two clinicians stated after reviewing the pump settings the drug was programmed correctly into the pump, and there was a dual nurse verification. The nurses involved report setting the drip as a "basic infusion. " the hydromorphone bag was not scanned by the nurse. The nurse entered the room 2. 5 hours later, and the bag was "dry. " it was observed that the patient was drowsy but alert and talking and stated her pain was under control. It was noted that the md documented, "called by the nurse, who accidentally administered a 50mg bag of dilaudid over a period of two hours that was meant for a pca. " per the pharmacist, "the drip was not intended for pca. It should have been standard pump infusion using the library and guardrails. " the patient was transferred to the icu and started on a naloxone infusion. It was reported that within a few hours, the patient reported of pain, the narcan drip was titrated off, and the patient resumed on prn pain meds. The biomed checked the pump and it appeared to be working appropriately.
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Manufacturer (Section D)
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
MDR Report Key9827554
MDR Text Key188362354
Report Number9616066-2020-00896
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 03/12/2020 Patient Sequence Number: 1