MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; CURAPLEX ADULT PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, FILTER, PEEP VALVE & MAS

Model Number 2422-BVMPAD

Device Problem Pressure Problem (3012)

Event Date 07/27/2023

Event Type  Injury  

Event Description

Patient presentation: an semi-responsive patient, suffering from a cerebral vascular accident (cva), was assessed with a glasgow coma scale (gcs) score of 8, indicative of severe consciousness impairment.Medical interventions: rapid sequence intubation (rsi) was performed to establish airway patency.The endotracheal tube (ett) was ventilated with an adult curaplex (2422-bvmpad) manual resuscitator with a manometer, positive end-expiratory pressure (peep) valve set at 15 cmh2o, heat and moisture exchange filter (hmfe), in-line end-tidal co2 (etco2) sensor and connected to a 15 umin oxygen source.Fic02 elevation issue: while using the curaplex manual resuscitator, the patient's fraction of inspired co2 (fico2) levels increased until the clinical team placed the patient on a ventilator.This increase began at 12:45.10 (figure 1) and peaked at 27 mmhg at 12:46.30 (figure 2).Fico2 levels fluctuated between 10 and 20 mmhg (figure 3) until the patient was transitioned to a ventilator at 12:48.25.The elevation in fico2 resolved once the ventilator was initiated (figure 4).Product problem: suspicions arise that the manual resuscitator may be the source of the abnormal fic02 elevation.The fic02 increase poses a risk of hypercapnia, which can significantly impact the patient's bodily functions, physical well-being, and potentially lead to life-threatening consequences.Furthermore, this inconsistency raises concerns regarding adherence to performance specifications and user expectations.Patient outcome: the patients outcome is unknown, as care was handed over to another provider.

Manufacturer Narrative

The manual resuscitator may be the source of abnormal fico2 elevation.This is the issue that was referred to in the field notification initiated on oct 11, 2023.In addition, the fda medwatch report was received.

Event Description

Patient presentation: an semi-responsive patient, suffering from a cerebral vascular accident (cva), was assessed with a glasgow coma scale (gcs) score of 8, indicative of severe consciousness impairment.Medical interventions: rapid sequence intubation (rsi) was performed to establish airway patency.The endotracheal tube (ett) was ventilated with an adult curaplex (2422-bvmpad) manual resuscitator with a manometer, positive end-expiratory pressure (peep) valve set at 15 cmh2o, heat and moisture exchange filter (hmfe), in-line end-tidal co2 (etco2) sensor and connected to a 15 umin oxygen source.Fic02 elevation issue: while using the curaplex manual resuscitator, the patient's fraction of inspired co2 (fico2) levels increased until the clinical team placed the patient on a ventilator.This increase began at 12:45.10 (figure 1) and peaked at 27 mmhg at 12:46.30 (figure 2).Fico2 levels fluctuated between 10 and 20 mmhg (figure 3) until the patient was transitioned to a ventilator at 12:48.25.The elevation in fico2 resolved once the ventilator was initiated (figure 4).Product problem: suspicions arise that the manual resuscitator may be the source of the abnormal fic02 elevation.The fic02 increase poses a risk of hypercapnia, which can significantly impact the patient's bodily functions, physical well-being, and potentially lead to life-threatening consequences.Furthermore, this inconsistency raises concerns regarding adherence to performance specifications and user expectations.Patient outcome: the patients outcome is unknown, as care was handed over to another provider.

Manufacturer Narrative

The manual resuscitator may be the source of abnormal fico2 elevation.This is the issue that was referred to in the field notification initiated on oct 11, 2023.In addition, the fda medwatch report was received.The complaint of "the manual resuscitator may be the source of abnormal fico2 elevation" regarding part 2442-bvmpad was confirmed to be associated with ncmr-02506.A resolution letter was not requested by the customer.

• Brand Name: SUNMED LLC
• Type of Device: CURAPLEX ADULT PREMIUM BVM W/ BAG RESERVOIR, MANOMETER, FILTER, PEEP VALVE & MAS
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18592410
• MDR Text Key: 333895619
• Report Number: 1314417-2024-00008
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2422-BVMPAD
• Device Catalogue Number: 2422-BVMPAD
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other