FDA Adverse Event Malfunction Summary report: N

MINI-CAP, DISCONNECT W/PVP-1SOLUTION

MDR report key: 1941255 · Received December 29, 2010

Report

Report Number: 1423500-2010-07364
Event Type: Malfunction
Date Received: December 29, 2010
Date of Event: December 1, 2010
Report Date: December 7, 2010
Manufacturer: BAXTER HEALTHCARE - CLEVELAND
Product Code: KDI
PMA / PMN Number: K895631
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT OF MOISTURE ON A MINICAP WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE REPORT WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

Description of Event or Problem · 1

A BAXTER CUSTOMER SERVICE SPECIALIST NOTIFIED (B)(4) VIA EMAIL OF A CUSTOMER REPORTING AN ISSUE WITH HER NEW BOX OF MINICAPS. THE CUSTOMER REPORTED THAT WHEN SHE WAS PUTTING ON THE MINICAP SHE NOTICED A DROP OF WATER ON THE TIP OF THE MINICAP. THE CUSTOMER ADVISED THE CUSTOMER SPECIALIST THAT SHE WOULD CALL HER NURSE TO MAKE SURE SHE'S NOT GOING TO GET AN INFECTION. NO FURTHER DETAIL IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MINI-CAP, DISCONNECT W/PVP-1SOLUTION	DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM	KDI	BAXTER HEALTHCARE - CLEVELAND

Patients

Seq	Age	Sex	Outcome	Treatment
1	43 YR			MINICAP TRANSFER SET