MAUDE Adverse Event Report: ST PAUL

Device Problems Power Problem (3010); Complete Loss of Power (4015)

Patient Problems Hypoxia (1918); Seizures (2063)

Event Date 06/29/2020

Event Type  Injury  

Event Description

Information received a smiths medical pump per medwatch: called patient to complete his order for remodulin and titration and per his brother, he is currently in the hospital and has been for two days.His remodulin pump shut off, they don't know for how long or why and he ended up having a seizure.A male (b)(6) years of age is on remodulin mdv, strength: 5mb\ml.For pulmonary arterial hypertension.Also prescribed leap.No pump was returned and unknown serial number, as patient resides still in hospital.Seizures can be a result of hypoxia which may have been contributed by pump malfunction.The diagnoses of arterial pulmonary hypertension would have experienced altered respiratory status.This would cause occlusion to arterial arteries preventing lung expansion and oxygen exchange in the aveoli lung tissue.

• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10359178
• MDR Text Key: 201506811
• Report Number: 3012307300-2020-07747
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR