MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems High Blood Pressure/ Hypertension (1908); Overdose (1988); Tachycardia (2095)

Event Date 08/05/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that a cadd ambulatory infusion pump was involved in a morphine overinfusion incident caused by a user-induced programming error.The patient was undergoing an analgesic treatment when the nurse prepared a morphine cassette (1000 mg in 100 ml).A half hour after the start of the infusion, the nurse reprogrammed the pump.Four hours after the reprogramming, the patient had the following symptoms: felt poor and uncomfortable, arterial hypertension (200/100 mmhg), and tachycardia (170 beats per minute).The patient was conscious (glasgow score: 15).It was observed by the nurse that the morphine cassette was unexpectedly almost empty and that the pump was programmed as 13 ml/hour instead of 13 mg/hour, leading to morphine overinfusion.The infusion was stopped immediately at that time.A half hour after the issue was addressed, it was noted that the patient had improved hemodynamic values.No permanent injury was reported.

• Brand Name: CADD® AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 3350 granada avenue; oakdale MN 55128
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6216350
• MDR Text Key: 63663740
• Report Number: 3012307300-2016-00674
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR