MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME MINICAP TRANSFER SET; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number R5C4482

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a minicap transfer set leaked during patient use.The reporter stated that the patient had closed the roller sleeve and heard a noise, then disconnected the solution bag.The transfer set had then leaked.While the transfer set was being replaced, the roller sleeve came loose from the set.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A visual inspection with magnification noted broken occluder feet.Underwater leak testing, clear passage testing, and clamp function testing were performed.Underwater leak testing and clamp function testing noted a leak through the set.The reported condition was verified.The cause of the leak was determined to be broken occluder feet.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: MINICAP TRANSFER SET
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5214034
• MDR Text Key: 31087508
• Report Number: 1416980-2015-41501
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1