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

Catalog Number	5C4449
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a minicap extended life pd transfer set leaked; further described as ¿solution began to spray from the transfer set¿.This was observed during use of the device for peritoneal dialysis therapy.It was further reported the nurse discovered a "slice on the tubing¿.The transfer set was replaced.There was no report of patient injury; however, the patient was given prophylactic antibiotics as a precautionary measure.No additional information is available.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed, and it was noted that there was a leak from the tubing approximately ½ inch below the blue connector.It was also observed that the set showed signs of severe deterioration by excessive usage conditions.The tubing integrity had been compromised with the tubing having deteriorated by repetitive usage and chemical agent exposure.Functional leak testing was performed, and a leak was noted from the silicone tubing.The reported condition was verified.The cause of the reported condition could not be determined; however, as the set was returned in a severely deteriorated condition, which could suggest a user error.The tubing integrity could have been compromised by the patient usage conditions of the set and appeared to be weakened from the repetitive use of the roller clamp and the cleaning agents exposed to the set.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.

• Brand Name: MINICAP TRANSFER SET
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11682171
• Report Number: 1416980-2021-02193
• Device Sequence Number: 3511392
• Product Code: KDJ
• UDI-Device Identifier: 00085412050867
• UDI-Public: (01)00085412050867
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K152675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/07/2024
• Device Catalogue Number: 5C4449
• Device Lot Number: H19E07052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/17/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1