MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2H5660

Device Problem Backflow (1064)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  Injury  

Manufacturer Narrative

Device manufacturer address 1: (b)(4).The device was received and is currently awaiting evaluation completion.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported blood was backing up with a non-dehp extension set.The event was further reported, furthermore, the patient was ¿desaturating continuously with up titrating fio2 on the hfnc¿ (high flow nasal canula).The patient was emergently intubated, and the nurse observed ¿the patient's remodulin line that was infusing from the iv pump had blood backed up on the tubing¿.The iv pump ¿never alarmed¿ occlusion.The remodulin was running at 71 mg/kg/minute.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Upon follow up it was reported the vascular catheter was located at the intra-jugular (ij) and was deemed patent at the time of intubation.It was reported ¿the whole set was changed immediately after the patient was intubated".The patient was recovered from oxygen desaturation following intubation.F2 - the customer reported this event to the fda through medwatch 0502620000-2021-8020.The device was received for evaluation.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional testing including leak testing and clear passage under water testing was performed with no issues noted.The reported condition was not verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B4/f8: date of this report in mdr follow up #1 is being corrected from blank to 06/21/2021.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11921223
• MDR Text Key: 253758413
• Report Number: 1416980-2021-03284
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412065328
• UDI-Public: (01)00085412065328
• Combination Product (y/n): Y
• PMA/PMN Number: K153158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2H5660
• Device Lot Number: R20G03039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HFNC.; REMODULIN.; SPECTRUM PUMP.; UNSPECIFIED IV PUMP.; HFNC; REMODULIN; UNSPECIFIED IV PUMP
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 71