MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PALINDROME; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	8888145063CP
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, there was a venous alarm 30 minutes before the end of the hemodialysis treatment.The device¿s adapters were still attached to the palindrome connectors and the blood was flowing out of the venous side.The patient was dizzy and had lost an unmeasurable amount of blood.The doctor was informed, and the patient had to be resuscitated.After resuscitation measures in intensive care, the patient was stable.The patient is alive with cerebral damage due to blood loss and lack of oxygen.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The physical sample involved in the reported incident was not returned for evaluation.Seven photos were provided by the customer.Visual evaluation of these photos was performed.The first two pictures showed a package of b.Braun bloodlines.In the third and fourth, the tubing set could be seen inside of the package.Adapter disconnection or any other condition was not observed in these pictures.In the last three pictures a bottle of antiseptic was observed.In these images, no issues could be observed related to the adapter.Two b.Braun bloodline kits were received for analysis and investigation.The catheter was not returned for evaluation, therefore a catheter from lab stock was used to verify the reported condition.The b.Braun blood set and the adapters were connected and disconnected without difficulty several times.Based on the pictures and the b.Braun blood kits received, the complaint was not confirmed.It can be concluded that the product was manufactured according to specifications.Therefore, the most probable root cause could be considered as excessive force or an incorrect connection during use.No trends or triggers have been found.Therefore, no action is deemed necessary at this time.It must be noted that in-process are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PALINDROME
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7086767
• Report Number: 3009211636-2017-05377
• Device Sequence Number: 1450843
• Product Code: MSD
• UDI-Device Identifier: 10884521158344
• UDI-Public: 10884521158344
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/08/2018
• Device Model Number: 8888145063CP
• Device Catalogue Number: 8888145063CP
• Device Lot Number: 1520200145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 12/26/2017; 01/05/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 01/17/2018; 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79