MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 10/28/2017

Event Type  Injury  

Manufacturer Narrative

A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A facility hemodialysis (hd) registered nurse (rn) reported as after a hd patient had completed treatment and the patient was disconnecting, the arterial line popped off and arterial port was stuck in the patient's catheter.The patient had to go to the hospital to get the catheter replaced.Additional information was obtained from the clinic manager, who confirmed there was no patient injury as a result of the reported issue.The clinic manager stated the issue may have been attributed to an overaggressive nurse that over-tightened the connection too securely.Per clinic manager the arterial port was initially unable to be removed and the patient had his catheter replaced as the clinic was unable to remove the arterial port connection from the patients catheter.The clinic manager stated the patient was able to resume subsequent hemodialysis treatments in-center without further issue.Per clinic manager the sample was discarded.

Manufacturer Narrative

Corrected: expiration date: 08/31/2017.Plant investigation: the device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.A supplemental medwatch report will be submitted upon completion of the investigation.

Event Description

A facility hemodialysis (hd) registered nurse (rn) reported as after a hd patient had completed treatment and the patient was disconnecting, the arterial line popped off and arterial port was stuck in the patient's catheter.The patient had to go to the hospital to get the catheter replaced.Additional information was obtained from the clinic manager, who confirmed there was no patient injury as a result of the reported issue.The clinic manager stated the issue may have been attributed to an overaggressive nurse that over-tightened the connection too securely.Per clinic manager the arterial port was initially unable to be removed and the patient had his catheter replaced as the clinic was unable to remove the arterial port connection from the patients catheter.The clinic manager stated the patient was able to resume subsequent hemodialysis treatments in-center without further issue.Per clinic manager the sample was discarded.

Manufacturer Narrative

Corrected initial reporter occupation: health care professional removed.(b)(4).Conclusion: a temporal relationship exists between the fresenius combi-set blood line becoming stuck in the arterial luer lock connection of the hd catheter (not a fresenius product) thus necessitating hd catheter (not a fresenius product) replacement.The possibility exists the incident was related to an over-tighten connection at the user facility.However, based on the available information it could not be confirmed what may have caused the combi set luer to become lodged within the patients arterial hd catheter (not a fresenius product) luer.The combi set blood line in use at the time of the incident was not available for product investigation, as the sample was discarded at the user facility.

Event Description

Information in the complaint file was reviewed by a post market surveillance clinician.On (b)(6) 2017, after this patients scheduled hemodialysis (hd) treatment session was about to complete, the arterial luer lock of the combi set blood line connection detached and got firmly embedded and retained within the patients hd luer vascular access catheter (a non-fresenius product).Consequently, this this patient warranted hospitalization for placement of a new vascular access catheter (a non-fresenius product).Follow-up with the clinic manager on (b)(6) 2017 reported that this incident could possibly have resulted from overtightening of the connections between the combi set blood line and the patients vascular access arterial luer lock.The combi set line that encountered the problem was discarded after the reported incident at the user facility.The patient since then has resumed regular scheduled hd treatments without further reported issues.

• Brand Name: CUSTOM COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7068389
• MDR Text Key: 93246377
• Report Number: 8030665-2017-01046
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 17KR01145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 73