This is the third of three reports (same product id, same patient, similar problem).This is in regards to the limitorr#3.Linked to mfg report numbers: 2648988-2014-00067 and 2648988-2014-00068.The female patient had the limitorr (#1) on and the nurse found the stopcock had failed.The tubing fell apart and the patient overdrained cerebrospinal fluid (csf).They put another limitorr (#2) on and that one too failed a short time later (time unknown).A third limitorr (#3) was opened and while setting up, the tubing came out of the stopcock.Limitorr #3 was never attached to the patient.The patient had to have a new drain (becker) put in.It was reported that the patient had headache and leg/foot pain due to the overdrainage.Additional was requested an on 03dec2014 and 04dec2014, the following was provided by the customer: the (b)(6) female patient with an underlying condition of subarachnoid hemorrhage had limitorr placement to drain csf from the lumbar spine.Limitorr#1: the customer was just told that limitorr#1 leaked and it was replaced with limitorr#2.The customer was not told or given details surrounding limitorr#1, including when it was originally placed.Limittor #1 is not available for evaluation.Limitorr #2: limitorr #2 was first placed/used on patient on (b)(6) 2014 at 2200.Limitorr #2 failed on (b)(6) 2014 at 1315, leaked at the stopcock.With regards to how frequent the patient line stopcock was manipulated and for what process, the customer reported that the patient was on bed rest so the stopcock was not manipulated.The patient was being turned in bed every 2 hours as per hospital policy.It was reported that most patients with this injury do receive daily "ct's".It was unknown how much csf overdrainage was due to the limitorr #2 although hourly csf drainage were recorded in charting up until 1400.As far as the customer knows, the patient did not experience any leg/foot pain.The patient however experienced hypertension, systolic blood pressure (sbp) >220, headache (ha) and ectopy on cardiac monitor.The drain was replaced using sterile technique.The patient was medicated for comfort and broad spectrum antibiotics was started on the patient.Limitorr #2 has been sent back for evaluation.Limitorr#3: date limitorr #3 was opened/tried to be used on (b)(6) 2014 at 1345.However, it was never placed in the patient.This drain was taken out of the packaging by the medical doctor (md) and inspected.It had come apart at the seam/connection point in the tubing.After further discussion with the md, they did put tension by pulling the tubing to see if it would take much force to make it come apart.According to the md's, little pulling force was utilized to make it come apart.This limitorr#3 has been sent back for evaluation.Since limitorr#2 needed to be replaced and limitorr#3 fell apart, a competitor drainage (becker) was used instead.Patient outcome was reported as "patient is doing well".
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