MAUDE Adverse Event Report: CAREFUSION, INC SHUNT PAK, 11.5FR DOUBLE-VALVE; SHUNT, PERITONEAL

Catalog Number 42-2090

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  Injury  

Event Description

This report is about defective pump chamber.Liquid did not drain even when the chamber was pressed.Takuma tsuji 9/14/2023: following information is obtained.- was the catheter occluded it is unknown if there was occlusion.- what was the impact to the patient? no patient injury.- is there a photo or sample available showing the reported issue? yes.The sample will be returned.- when was the shunt placed? (b)(6) 2023 - did the shunt require replacement due to this event? if no, how was the issue resolved? the shunt was replaced.- was there any medical intervention required including diagnostics, procedures, and treatment delay? not provided.

Manufacturer Narrative

(b)(4).Initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: a0202.Patient problem code: f23.

Manufacturer Narrative

(b)(6) follow-up emdr for device evaluation: one shunt was received by our quality team for investigation.Upon visual inspection, it was observed that the perineal end of the tubing had been cut off.There was sodium bicarbonate evenly distributed throughout the body and the valves, so no issues with fused valves were observed.Water was pumped through with a minor delay at start up, but the shunt functioned properly.We are unsure whether the tubing being cut contributed to a minor delay; therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001482695 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.Awareness training will be performed with the operator.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

Event Description

This report is about defective pump chamber.Liquid did not drain even when the chamber was pressed.(b)(6) 9/14/2023: following information is obtained.Was the catheter occluded it is unknown if there was occlusion.What was the impact to the patient? no patient injury.Is there a photo or sample available showing the reported issue? yes.The sample will be returned.When was the shunt placed? (b)(6) 2023 did the shunt require replacement due to this event? if no, how was the issue resolved? the shunt was replaced.Was there any medical intervention required including diagnostics, procedures, and treatment delay? not provided.

• Brand Name: SHUNT PAK, 11.5FR DOUBLE-VALVE
• Type of Device: SHUNT, PERITONEAL
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17842770
• MDR Text Key: 324572119
• Report Number: 1625685-2023-00097
• Device Sequence Number: 1
• Product Code: KPM
• UDI-Device Identifier: 50885403421370
• UDI-Public: (01)50885403421370
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42-2090
• Device Lot Number: 0001482695
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other