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WILLIAM A. COOK AUSTRALIA, PTY LTD VACUUM PUMP; MQG ACCESSORY, ASSISTED REPRODUCTION - COOK ULTRA QUIET VACUUM PUMP/ACCESS
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| Catalog Number K-MAR-5200 |
| Device Problem
Off-Label Use (1494)
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| Patient Problem
Hemorrhage/Bleeding (1888)
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Event Type
Injury
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Manufacturer Narrative
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The event information came from review of a journal article: ke, x., lin, y.-h., & wang, f.(2021).Non-surgical treatment for hematocele in the bladder associated with ascites puncture in a patient with ovarian hyperstimulation syndrome: a case report.Postgraduate medicine, 133(1), 112-116.Doi: 10.1080/00325481.2020.1827889.
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Event Description
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The event information came from review of a journal article: ke, x., lin, y.-h., & wang, f.(2021).Non-surgical treatment for hematocele in the bladder associated with ascites puncture in a patient with ovarian hyperstimulation syndrome: a case report.Postgraduate medicine, 133(1), 112-116.Doi: 10.1080/00325481.2020.1827889.Potential off-label use of k-mar-5200 in ascites puncture for the treatment of ovarian hyperstimulation syndrome (ohss).A case report of a 28-year-old woman who presented with hematuria and dysuria following tv puncture for ascites aspiration for ohss: twenty-nine oocytes were collected, no fresh embryo was transferred because of ohss, and the embryos were cryopreserved.At 6 days after egg collection, she presented with signs including oliguria (decreased urine output caused by impaired venous return), hydrothorax, and ascites.Tv sonography revealed bilateral enlarged ovaries with multilocular cysts (right ovary 12.9*11.7 cm, left ovary 13.6*10.7 cm), ascites (vesicouterine pouch 9.9 cm*6.6 cm, rectouterine fossa 5.2*2.5 cm) and unilateral pleural effusions (right: 3.6 cm).Laboratory work-up indicated normal partial thromboplastin times and prothrombin, increased plasma d-dimer (2.5 ug/ml), hemoconcentration (hematocrit, 42.5%) and, hypoproteinemia (albumin concentration 2.4 g/dl), which were considered to indicate severe ohss.We initiated conservative treatments.Thromboembolic prophylaxis was maintained with low molecular weight heparin (5,000 iu/day), and hetastarch and human albumin were injected to preserve the volume of the intravascular space.Nevertheless, the patient still felt abdominal distension and mild dyspnea, so we proceeded to ascites puncture.The patient¿s abdominal wall was thick (estimated at 10 cm) which made ultrasonic imaging of internal organs unclear.In addition, she underwent psychological preparation to accept the pain of tv puncture for oocyte collection rather than a new abdominal wound.Therefore, she chose tv b-ultrasound-guided ascites puncture.The patient was asked to empty her bladder before the puncture.In brief, the tv ultrasound probe with the needle guide was inserted directly into the vagina.Once a possible safe pathway from the vagina was identified through ultrasonography, a 17-gauge, 20-cm chiba needle was used for access.The pressure of the negative pressure pump (k-mar-5200; cook medical) was adjusted to 200 mmhg, and 2000 ml fluid was discharged (relatively small amounts of fluid were drained limited by the presence of the large ovaries adhering to the drainage needle).The operation lasted for 1 h, and the patient reported no discomfort during the operation.The operation was completed after no exudation was detected at the puncture site.At 4 h after puncture, the patient presented to the emergency department because of hematuria and dysuria, with no abdominal pain.Emergency b-ultrasonography revealed filling of the bladder, with an 8.33 cm×4.88 cm well-defined loose floccus and echoless area, and no obvious blood flow signal was seen.The echoless area was suspected of being a blood clot with urinary retention following bladder injury by the puncture needle.Therefore, an indwelling two-way catheter was placed, and about 20 ml of gross hematuria was discharged, with inadequate urine drainage.At 2 h after the placement of the two-way catheter, b-ultrasonography revealed that the size of blood clot remained unchanged.The routine blood examination performed in the emergency department showed the following results: hemoglobin (hgb) level, 111 g/l; white blood cell (wbc) count, 8.3 × 109/l; neutrophil count (neut%), 73%; and hematocrit (hct) level, 33.2%.B-ultrasonography revealed no abnormality in the ureters and kidneys.A urologist was consulted.Considering that there was no active bleeding or injury to the ureter, the two-way catheter was replaced with a 22- french three-way foley catheter.In addition, a 50-ml syringe, which was connected to the catheter, was used to collect 50 ml of the pre-heated 0.9% normal saline to irrigate and suction the blood clots inside the bladder at a high rate.This process was repeated three times, and about 200 ml of a dark, red mixture of blood clots and normal saline was drawn.The patient was advised to rest.The following day, the routine blood examination was repeated and showed the following: hgb level, 108 g/l; wbc count, 7.4 × 109/l; neut%, 74%; and hct level, 32.8%.Liver and kidney function showed no obvious abnormality.B-ultrasonography revealed the presence of 4.9 × 3.6 cm and 5.3 × 5.1 cm blood clots inside the bladder and on the right wall of the bladder (figure 2).Thus, cystoscopy was not considered, and the patient underwent abdominal b-ultrasound guided bladder irrigation in the operating room.The bladder was distended with approximately 250 cc of sterile saline to create a sonographic window and improve visualization using a 50-ml syringe at first, and then 200 ml of fluid was suctioned.Large blood clots were pulled into the small ones using the surging force at the time of injection and suction.Then, the mixture of fragmented blood clots and 0.9% normal saline was suctioned.The bladder was repeatedly irrigated and suctioned until b-ultrasonography revealed only 3-cm blood clots in the bladder).An indwelling catheter was placed, urine flowed out smoothly, and the patient was advised to drink a lot of water.The blood clots were discharged spontaneously and intermittently after irrigation.On the following day, her urine became clear, and b-ultrasonography revealed a normal bladder with no floccule inside.Therefore, the indwelling catheter was removed for normal spontaneous urination.One week later, no symptom of urinary tract infection was observed.The patient was discharged home with the disappearance of ohss symptoms and signs.Six months later, the patient had a clinical pregnancy through an artificial cycle of frozen embryo transfer.
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Event Description
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The event information came from review of a journal article: ke, x., lin, y.-h., & wang, f.(2021).Non-surgical treatment for hematocele in the bladder associated with ascites puncture in a patient with ovarian hyperstimulation syndrome: a case report.Postgraduate medicine, 133(1), 112-116.Doi: 10.1080/00325481.2020.1827889.Potential off-label use of k-mar-5200 in ascites puncture for the treatment of ovarian hyperstimulation syndrome (ohss).A case report of a 28-year-old woman who presented with hematuria and dysuria following tv puncture for ascites aspiration for ohss: twenty-nine oocytes were collected, no fresh embryo was transferred because of ohss, and the embryos were cryopreserved.At 6 days after egg collection, she presented with signs including oliguria (decreased urine output caused by impaired venous return), hydrothorax, and ascites.Tv sonography revealed bilateral enlarged ovaries with multilocular cysts (right ovary 12.9/11.7 cm, left ovary 13.6/10.7 cm), ascites (vesicouterine pouch 9.9 cm/6.6 cm, rectouterine fossa 5.2/2.5 cm) and unilateral pleural effusions (right: 3.6 cm).Laboratory work-up indicated normal partial thromboplastin times and prothrombin, increased plasma d-dimer (2.5 ug/ml), hemoconcentration (hematocrit, 42.5%) and, hypoproteinemia (albumin concentration 2.4 g/dl), which were considered to indicate severe ohss.We initiated conservative treatments.Thromboembolic prophylaxis was maintained with low molecular weight heparin (5,000 iu/day), and hetastarch and human albumin were injected to preserve the volume of the intravascular space.Nevertheless, the patient still felt abdominal distension and mild dyspnea, so we proceeded to ascites puncture.The patient¿s abdominal wall was thick (estimated at 10 cm) which made ultrasonic imaging of internal organs unclear.In addition, she underwent psychological preparation to accept the pain of tv puncture for oocyte collection rather than a new abdominal wound.Therefore, she chose tv b-ultrasound-guided ascites puncture.The patient was asked to empty her bladder before the puncture.In brief, the tv ultrasound probe with the needle guide was inserted directly into the vagina.Once a possible safe pathway from the vagina was identified through ultrasonography, a 17-gauge, 20-cm chiba needle was used for access.The pressure of the negative pressure pump (k-mar-5200; cook medical) was adjusted to 200 mmhg, and 2000 ml fluid was discharged (relatively small amounts of fluid were drained limited by the presence of the large ovaries adhering to the drainage needle).The operation lasted for 1 h, and the patient reported no discomfort during the operation.The operation was completed after no exudation was detected at the puncture site.At 4 h after puncture, the patient presented to the emergency department because of hematuria and dysuria, with no abdominal pain.Emergency b-ultrasonography revealed filling of the bladder, with an 8.33 cm×4.88 cm well-defined loose floccus and echoless area, and no obvious blood flow signal was seen.The echoless area was suspected of being a blood clot with urinary retention following bladder injury by the puncture needle.Therefore, an indwelling two-way catheter was placed, and about 20 ml of gross hematuria was discharged, with inadequate urine drainage.At 2 h after the placement of the two-way catheter, b-ultrasonography revealed that the size of blood clot remained unchanged.The routine blood examination performed in the emergency department showed the following results: hemoglobin (hgb) level, 111 g/l; white blood cell (wbc) count, 8.3 × 109/l; neutrophil count (neut%), 73%; and hematocrit (hct) level, 33.2%.B-ultrasonography revealed no abnormality in the ureters and kidneys.A urologist was consulted.Considering that there was no active bleeding or injury to the ureter, the two-way catheter was replaced with a 22- french three-way foley catheter.In addition, a 50-ml syringe, which was connected to the catheter, was used to collect 50 ml of the pre-heated 0.9% normal saline to irrigate and suction the blood clots inside the bladder at a high rate.This process was repeated three times, and about 200 ml of a dark, red mixture of blood clots and normal saline was drawn.The patient was advised to rest.The following day, the routine blood examination was repeated and showed the following: hgb level, 108 g/l; wbc count, 7.4 × 109/l; neut%, 74%; and hct level, 32.8%.Liver and kidney function showed no obvious abnormality.B-ultrasonography revealed the presence of 4.9 × 3.6 cm and 5.3 × 5.1 cm blood clots inside the bladder and on the right wall of the bladder (figure 2).Thus, cystoscopy was not considered, and the patient underwent abdominal b-ultrasound guided bladder irrigation in the operating room.The bladder was distended with approximately 250 cc of sterile saline to create a sonographic window and improve visualization using a 50-ml syringe at first, and then 200 ml of fluid was suctioned.Large blood clots were pulled into the small ones using the surging force at the time of injection and suction.Then, the mixture of fragmented blood clots and 0.9% normal saline was suctioned.The bladder was repeatedly irrigated and suctioned until b-ultrasonography revealed only 3-cm blood clots in the bladder).An indwelling catheter was placed, urine flowed out smoothly, and the patient was advised to drink a lot of water.The blood clots were discharged spontaneously and intermittently after irrigation.On the following day, her urine became clear, and b-ultrasonography revealed a normal bladder with no floccule inside.Therefore, the indwelling catheter was removed for normal spontaneous urination.One week later, no symptom of urinary tract infection was observed.The patient was discharged home with the disappearance of ohss symptoms and signs.Six months later, the patient had a clinical pregnancy through an artificial cycle of frozen embryo transfer.
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Manufacturer Narrative
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No part of the device was returned for evaluation.No imaging was received to assist the investigation.The complaint information was provided to the medical director in order to provide a clinical assessment, he stated the following: "aspirating free peritoneal fluid is a relatively common surgical event.The so-called pouch of douglas is a potential space between the uterus and ovaries, and the rectum.It includes the lowest point in the peritoneal cavity in a standing person.Any free fluid within the peritoneal cavity will under the force of gravity, tend to accumulate in that pouch preferentially.Ovarian hyperstimulation syndrome (ohss) is an uncommon but potentially lethal complication of ovarian hyperstimulation to obtain mature follicles with oocytes with in them.A fundamental pathology is that blood vessels become ¿leaky¿ to the main proteins within blood, especially albumin.Where albumin goes, body fluid follows.The blood becomes thicker, raising the risk of venous thrombosis.Patients with ohss thus develop generalized oedema ¿ the accumulation of free fluid within body tissues.A characteristic event is that free fluid gathers within the chest cavity, and within the abdominal cavity.Both of these are a result of the same cause.The amount of fluid that gathers intra-abdominally can be 5+ litres.This causes pressure on the veins to the patients¿ kidneys, and renal failure develops.Drainage of that fluid interrupts the spiral of consequences, so it is clear that in this patient¿s care, the correct plan was to drain some or all of the intraperitoneal fluid.Traditionally, a needle insertion of a semi-permanent plastic catheter through the abdominal wall into an ultrasound guided ¿pool¿ of fluid allows the fluid to be taken off in aliquots, until symptoms are relieved.A key point is that the softer catheter end is unlikely to damage bowel or other mobile organs.This case description makes it clear that ultrasound transabdominally gave poor views.Transvaginal ultrasound gives a view without the difficulty of having to ¿see¿ through layered fat.The patient gave consent to use of transvaginal ultrasound guided aspiration of free pelvic fluid.The use of the k-mar 5200 is where i have doubts.In my experience, the pressure of the fluid means that just providing drainage without suction is usually sufficient.If suction is used, the natural consequence is that any organs nearby will be sucked towards the tip of the (sharp) needle.The case notes say that the enlarged ovaries kept blocking off the needle tip, presumably because of that suction pressure.Without fluid at the tip of the ultrasound probe, the view is compromised.A particular problem with free peritoneal fluid is that all organs are so much more mobile than usual.Bowel is difficult to avoid.In the presence of poor views, it is not a surprise that the needle traversed the bladder wall, causing unseen damage and bleeding into the bladder.The subsequent management of the bladder haematomata with the assistance of the urologist is uneventful.Although it is not specified, the suction used at this later stage was firstly drawing back on a 50ml syringe, and later i take it that the urologist used routine theatre suction machines.He/she is extremely unlikely to have ever used the k-mar 5200.In any case, the suction was from a closed space, through a plastic soft catheter.My final comment is that in most hospitals, a patient with chest and abdominal free fluid would be managed within an intensive care unit, because this is a complex, life threatening condition affecting multiple body organs and systems, and intensivists are usually the most skilled doctors to manage such cases.In summary, this patient was very sick, and needed fluid drainage urgently.Her physique made ultrasound control unsatisfactory for safe placement of an abdominal catheter/drain.The use of a sharp needle with suction of any sort increased the risks for this patient.This was definitely off-label use.The hard part is that, in every oocyte retrieval we use sharp needle and suction, and as i started with, occasionally a surgeon will suck dry the pouch of douglas as the procedure is completed if, say, the egg number has been less than expected".Manufacturing records review could not be completed as the lot number is unknown.Review of the instructions for use (ifu) supplied with the device states: 1.Safety instructions: always work with the one-way hydrophobic filter between the collection receptacle and the vacuum pump to prevent body fluids from entering the device.Never use the vacuum pump if there is any indication that the tube, the filter or the device is contaminated.Do not allow any further use of the device.Immediately notify your authorised service agent to have the device checked and repaired.Always monitor the aspiration vacuum level.An excessive vacuum can lead to damage of the oocyte or other body tissue.2.1 indications for use: the cook vacuum pump is intended for the aspiration of eggs (ova), during assisted reproduction procedures using low flow, intermittent vacuum.10.1 liability: because cook australia has no control or influence over the conditions under which this device is used, over its method of use or administration, or on handling of the product after it leaves its possession, cook australia takes no responsibility for the results, use and/or performance of the product.Cook australia expects that use of the product will be confined to trained and expert users.There is evidence to suggest that the user did not follow the instructions for use.This is a confirmed complaint as there is no evidence to discredit the validity of this claim.The event information was taken from a literature article: ke, x., lin, y.-h., & wang, f.(2021).Non-surgical treatment for hematocele in the bladder associated with ascites puncture in a patient with ovarian hyperstimulation syndrome: a case report.Postgraduate medicine, 133(1), 112-116.Doi: 10.1080/00325481.2020.1827889.The complaint reported that ¿potential off-label use of k-mar-5200 in ascites puncture for the treatment of ovarian hyperstimulation syndrome (ohss).A case report of a 28-year-old woman who presented with hematuria and dysuria following tv puncture for ascites aspiration for ohss".
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