MAUDE Adverse Event Report: CAREFUSION, INC PLEURX DRAINAGE KIT 1000ML; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Catalog Number 50-7510

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hypervolemia (2664)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - a follow up esubmission will be completed if additional information becomes available.

Event Description

It was stated that after 2 separate drainages of 400 ml the spouse contacted the physician as the patients dressing was saturated.The physician stated to present to the hospital as patient may require an additional suture at catheter site.It was determined that the patient was in fluid overload not requiring a suture and drained a total of 7 liters.Patient was observed due to the amount of fluid drained.The patient spouse reported the patient was released and doing well.

Event Description

No vacuum correction : updated malfunction to serious injury.

• Brand Name: PLEURX DRAINAGE KIT 1000ML
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 7018440
• MDR Text Key: 93003001
• Report Number: 9680904-2017-00222
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• PMA/PMN Number: K113854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Patient Family Member or Friend
• Device Catalogue Number: 50-7510
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other