MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. NONDEHP LS LF PLUMSET-OLCP D-CHAN; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 14687

Device Problem Crack (1135)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/20/2015

Event Type  Injury  

Manufacturer Narrative

The device was received.Investigation is not complete.Per medical assessment: the presented information refers to a ¿renal patient¿ that was being treated with levophed and vasopressin via a primary plum tubing set and a rymed connector.Patient¿s baseline systolic blood pressure (sbp) was reported in the range of 90-98 mm/hg while on vasopressin and levophed infusion.Per the customer, excessive force was applied when connecting the option-lok spin collar to the rymed connector, causing a crack of the spin collar.The customer contact reported a leak of unknown duration during this infusion and reported that patient¿s sbp was within the 60s range lasting over 2 ½ hours.Because of decreased sbp while on vasopressin and levophed infusion, the patient received a bolus of 500ml normal saline (999ml/hr) which is considered standard of care in a hypotensive patient and that¿s when the leak was discovered.This leak prompted the customer to change the tubing set and the connector and to resume therapy with levophed and vasopressin.Customer reported that patient¿s sbp returned to baseline levels after therapy was restart.If the patient¿s hypotensive episode was considered life-threatening, the medical staff would have investigated and treated the incident within minutes not hours.Based on the reported scenario and lack of information regarding patient¿s medical condition being treated, concomitant medication, medical history, etc, the hypotensive episode reported in this patient is not considered life-threatening.Therefore, hospira¿s device did not cause or contribute to a serious injury or death of this patient: thus, the cumulative weighted evidence is not consistent with a causal association or contribution of hospira¿s device to the adverse event.

Event Description

The customer contact reported that the primary plum tubing set was cracked at the connector site.The tubing set was connected to a rymed invision plus needless connector and was being used to deliver a max dose of levophed at 30mcg/min or approximately 65ml/hr and a max dose of vasopressin at 0.04mcg/min or 20ml/hr via a triple lumen peripherally inserted central catheter (picc).It was reported that the patient's baseline blood pressure while on levophed and vasopressin was between 90-98mmhg.After an unspecified length of time during the delivery, it was reported that the patient's systolic blood pressure decreased into the 60's for approximately 2.5 hours.During this time the clinician attempted to reposition the patient and the blood pressure cuff to assess for change in blood pressure.At an unspecified time, the patient received a 500 ml bolus of normal saline at a rate of 999ml/hr via the same pump, and a leak of solution was noted on the bed sheets.The tubing set and connector were changed, and the patient's blood pressure increased back to therapeutic range.Prior to the event, it was reported that the clinician asked the charge nurse for assistance with the connection site, and force was used, which may have caused the spin collar to crack.In addition, it was reported that the user facility has encountered previous problems with the rymed invision plus needless connectors cracking and causing leaks at the connection site.No additional information was provided.

Manufacturer Narrative

Preliminary testing and investigation were completed by the manufacturer.A visual inspection of the sample revealed that the spin collar of the option-lok was broken with a portion of the spin collar missing.White drag marks were present, indicating the use of force and confirming the allegation of a crack on the spin collar.An air test was performed with the sample under water, and there was no evidence of any leakage.The sample was also tested with the two rymed invision-plus adapters and, in both cases, there was no leak noted at the connection site between the option-lok spin collar and the rymed invision-plus adapter.Testing and investigation did not identify a probable cause that could contribute to the event reported by the customer, and the manufacturing process was discarded as a probable cause of the reported event.However, according to the event description, an excess of force or mishandling during the connection of the spin collar with the adapter connector could not be discarded.Hospira has initiated a formal investigation to address this issue.The investigation remains in progress.

Event Description

The customer contact reported that the primary plum tubing set was cracked at the connector site.The tubing set was connected to a rymed invision plus needless connector and was being used to deliver a max dose of levophed at 30mcg/min or approximately 65ml/hr and a max dose of vasopressin at 0.04mcg/min or 20ml/hr via a triple lumen peripherally inserted central catheter (picc).It was reported that the patient's baseline blood pressure while on levophed and vasopressin was between 90-98mmhg.After an unspecified length of time during the delivery, it was reported that the patient's systolic blood pressure decreased into the 60's for approximately 2.5 hours.During this time the clinician attempted to reposition the patient and the blood pressure cuff to assess for change in blood pressure.At an unspecified time, the patient received a 500 ml bolus of normal saline at a rate of 999ml/hr via the same pump, and a leak of solution was noted on the bed sheets.The tubing set and connector were changed, and the patient's blood pressure increased back to therapeutic range.Prior to the event, it was reported that the clinician asked the charge nurse for assistance with the connection site, and force was used, which may have caused the spin collar to crack.In addition, it was reported that the user facility has encountered previous problems with the rymed invision plus needless connectors cracking and causing leaks at the connection site.No additional information was provided.

Manufacturer Narrative

Testing and investigation is complete.Hospira completed a formal investigation to address the issue of the cracked spin collar.After an in-depth assessment, no root cause associated with hospira (b)(4) manufacturing processes could be identified.The condition could not be replicated and all evidence suggested that the spin collar lots involved were manufactured according to specifications, and the involved final lot, 58072-5h, was released to market conforming to specifications.A batch record review revealed no discrepancies that may have contributed to a complaint of this nature.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the final visual and physical evaluation results indicated that the product met specification requirements.A potential cause could be related to final user since according to complaint, it was reported that force was applied at the connection site and may have caused the crack at the spin collar.

Event Description

The customer contact reported that the primary plum tubing set was cracked at the connector site.The tubing set was connected to a rymed invision plus needless connector and was being used to deliver a max dose of levophed at 30mcg/min or approximately 65ml/hr and a max dose of vasopressin at 0.04mcg/min or 20ml/hr via a triple lumen peripherally inserted central catheter (picc).It was reported that the patients baseline blood pressure while on levophed and vasopressin was between 90-98mmhg.After an unspecified length of time during the delivery, it was reported that the patient's systolic blood pressure decreased into the 60s for approximately 2.5 hours.During this time the clinician attempted to reposition the patient and the blood pressure cuff to assess for change in blood pressure.At an unspecified time, the patient received a 500 ml bolus of normal saline at a rate of 999ml/hr via the same pump, and a leak of solution was noted on the bed sheets.The tubing set and connector were changed, and the patient's blood pressure increased back to therapeutic range.Prior to the event, it was reported that the clinician asked the charge nurse for assistance with the connection site, and force was used, which may have caused the spin collar to crack.In addition, it was reported that the user facility has encountered previous problems with the rymed invision plus needless connectors cracking and causing leaks at the connection site.No additional information was provided.

• Brand Name: NONDEHP LS LF PLUMSET-OLCP D-CHAN
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; 9615050; zona franca global,; la aurora heredia ; CS
• Manufacturer (Section G): HOSPIRA COSTA RICA LTD.; zona franca global,; la aurora heredia ; CS
• Manufacturer Contact: juergen schmider ; 275 n field drive; bldg. h2-1east, dept no. 097u; lake forest, IL 60645 ; 2242125740
• MDR Report Key: 5358446
• MDR Text Key: 35606720
• Report Number: 9615050-2016-00001
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 14687
• Device Lot Number: 580725H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other