MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PCA SET 86IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14279-28

Device Problem Infusion or Flow Problem (2964)

Patient Problems Overdose (1988); Oversedation (1990); Low Oxygen Saturation (2477)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is available for investigation.

Event Description

The event involved a ndehp pca set 86in that the customer reported a patient in the recovery room received a 6mg bolus of dilaudid.The customer stated the nurse used the pca tubing without the filter.The diagram they provided shows they used an extension set with a filter that has a 6ml prime volume attached to the end of the pca tubing.Hydration fluid was attached to the y site of the pca tubing.The hydration fluid was unclamped, which resulted in a flush of the extension set and the bolus of dilaudid.The patient spo2 decreased, vitals declined, and the patient became unresponsive.The patient received narcan a couple of times to reverse the effects of the pain medication.The patient ended up staying an extra day in the hospital.

Manufacturer Narrative

H10: no product samples or videos were returned for investigation.Images were returned which appear to show two different configurations of the same list number however the lot number was not provided for one sample.From the list number data, it is possible that the two sets are part of the same family of products and tuc (trades union congress) code, however not exactly the same list number.The full list number is 9 numbers, not the abbreviated list number seen on the package, the lot number would be required to verify this and it was unable to be retrieved.The complaint of differing sets cannot be confirmed without further information.A batch record review was performed to lot# 875725h, list# 14279-0489 and no discrepancies that may have contributed to a complaint of this nature were found.The quality inspection of final visual and physical evaluation results indicated that the product met specification requirements.This lot was manufacture on 03/23/18.Manufacturing quality (mq) performed visual and physical evaluation with zero defects found.Maintenance routines and maintenance work orders (wo) were not analyzed, since there are no machines involved that could be associated to the defect reported.No process changes, unusual event, re-work, re-processing or re-inspection activities were generated or performed to the batch mentioned above or its commodities.As a result, no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: NDEHP PCA SET 86IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 9368857
• MDR Text Key: 167785466
• Report Number: 9615050-2019-00462
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: K143612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14279-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DILAUDID, MFR UNK; DILAUDID, MFR UNK
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention